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"Vomiting - diagnosis"
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Combination of dexmedetomidine and esketamine for postoperative nausea and vomiting in patients undergoing laparoscopic surgery: study protocol for a prospective, randomized, controlled trial
2025
Background
Laparoscopic surgery has gained widespread acceptance due to its advantages over traditional open procedures, including less postoperative pain and faster recovery. However, postoperative nausea and vomiting (PONV) remains a prevalent complication, affecting up to 80% of high-risk patients and significantly reducing patient satisfaction and recovery quality. Although opioids are frequently used for intraoperative analgesia, their side effects, particularly PONV, highlight the need for opioid-sparing strategies. Dexmedetomidine and esketamine are two agents with analgesic and anesthetic-sparing properties that have shown promise individually in reducing PONV and postoperative pain. However, evidence remains limited, and no study has systematically evaluated the combined use of dexmedetomidine and esketamine for PONV prevention in laparoscopic surgery. This trial aims to fill this knowledge gap by assessing the efficacy and safety of this novel combination strategy, potentially offering an improved anesthetic regimen for enhanced postoperative recovery.
Methods
To address this gap, we propose a prospective, randomized, controlled trial (RCT) at a single center to evaluate the effects of dexmedetomidine and esketamine on PONV in laparoscopic surgery patients. Patients will be randomly assigned to either the combination therapy group or the control group in a 1:1 ratio. The combination therapy group (
n
= 70) will receive intravenous dexmedetomidine (0.5 μg/kg), esketamine (0.3 mg/kg), sufentanil (0.2 μg/kg) and propofol (1.5–2.0 mg/kg) for anesthesia induction, with sevoflurane (2–3%) used for maintenance during surgery. Conversely, the control group (
n
= 70) will receive sufentanil (0.5 μg/kg) and propofol (1.5–2.0 mg/kg) for anesthesia induction, followed by sevoflurane (2–3%) inhalation and continuous remifentanil infusion (0.1 μg/kg/min) for maintenance. The primary outcome is the incidence of PONV within 48 h postoperatively, assessed during three predefined intervals: 0–6 h, 6–24 h, and 24–48 h. Secondary outcomes include Apfel PONV risk score, pain scores at 0, 6, 12, 24, and 48 h postoperatively, time to first PONV episode and first rescue antiemetic, time to first rescue analgesic, total dosage and frequency of rescue analgesics and antiemetics within 48 h, patient satisfaction score at discharge, length of hospital stay, discharge condition, and the incidence and classification of adverse events.
Discusssion
This study aims to evaluate the safety and feasibility of combining dexmedetomidine and esketamine to prevent PONV in patients undergoing laparoscopic surgery. The findings may offer evidence for an effective opioid-reducing anesthesia strategy that enhances analgesia and supports recovery, with potential value for broader clinical application.
Trial registration {2a,2b}
Chinese Clinical Trial Register, ChiCTR2300072455. Registered on June 14, 2023.
Journal Article
The Benefits of Olanzapine in Palliating Symptoms
2021
Olanzapine has become a major drug in the management of chemotherapy-induced nausea and vomiting as a prophylactic agent. In addition, a recent randomized trial has demonstrated its benefits in treating nausea and vomiting associated with advanced cancer. The added benefit to olanzapine is that it also stimulates appetite. As a result, since it treats multiple symptoms associated with advanced cancer, it is likely to become the antiemetic of choice in palliative care at least in the USA. The added benefit of treating insomnia and the avoidance of benzodiazepines should place olanzapine in at the top of the list of drugs to use for patients who do complain of insomnia. There is no good evidence that it potentiates the respiratory depression of opioids unlike benzodiazepines. The evidence is weak that olanzapine in as an adjuvant analgesic. Hopefully, future trials will explore this in greater depth. The benefits of adding olanzapine to potent opioids are that it may reduce craving, drug cues, and opioid misuse. Other symptoms like anxiety and depression may be addressed by the addition of olanzapine to standard antidepressants.
Journal Article
A pilot study of the effect of a home‐based multimodal symptom‐management program in children and adolescents undergoing chemotherapy
by
Cheng, Karis Kin‐Fong
,
Tan, Laura Mei Lian
in
Adaptation, Psychological
,
Adolescent
,
adolescents
2021
Background Prevalent symptoms that affect children and adolescents throughout the process of cancer diagnosis and treatment include nausea and vomiting, fatigue, pain, mucositis, and anxiety. Aim To examine the effect of a home‐based multimodal symptom‐management program for alleviation of nausea and vomiting, fatigue, pain, mucositis, and anxiety in children and adolescents undergoing chemotherapy for hematological malignancies or solid tumors. Methods In an exploratory pilot randomized study with qualitative interview, patients between 10 and 18 years of age were randomly assigned to either the symptom‐management program plus usual care (intervention group) or usual care (control group). The program consisted of multiple nonpharmacological interventional components. The targeted symptoms were measured at baseline (after diagnosis), at the first 2 weeks of each cycle of chemotherapy, and at 6 months after baseline, using the Memorial Symptom Assessment Scale 10‐18 and the State Anxiety Scale for Children. Results Fifty children (31 boys; mean age, 13.7 years) were randomized either to the intervention group or the control group (25 each) and underwent baseline assessment. A comparison between the groups showed that the intervention group had a significant less fatigue over time (P < .05). However, no differences were found with respect to nausea and vomiting, pain, mucositis, and anxiety between groups. Both children and parents reported a positive experience with the symptom‐management program. Conclusion The home‐based symptom‐management program may have helped to reduce fatigue in children and adolescents undergoing chemotherapy. In addition, qualitative data support the importance of improving children and parents' knowledge, coping skills, and psychological preparation for symptoms associated with chemotherapy.
Journal Article
Effects of opioid-free anaesthesia on postoperative nausea and vomiting in patients undergoing video-assisted thoracoscopic surgery (OFA-PONV trial): study protocol for a randomised controlled trial
by
Yan, Xiang
,
Jiang, Jia
,
Liang, Chen
in
Adult
,
Anaesthesia
,
Analgesics, Opioid - adverse effects
2023
Background
Postoperative nausea and vomiting (PONV) is a common complication after general anaesthesia and is associated with morbidity and prolonged length of stay. Growing evidence suggest that opioid-free general anaesthesia (OFA) may reduce PONV in various surgical settings. We aim to evaluate the efficacy of OFA on the incidence of PONV compared with opioid-based anaesthesia among adults undergoing thoracoscopic surgery.
Methods
This is a prospective, single-centre, randomised controlled trial comparing OFA and opioid-based anaesthesia for thoracoscopic surgery. A total of 168 adults will be randomised with a 1:1 ratio to receive either opioid-free anaesthesia or opioid-based anaesthesia. The primary outcome will be the incidence of PONV within 24 h after operation. The secondary outcomes will include the severity of PONV, quality of recovery, pain at rest, 6-min walking test, and health-related quality of life after operation.
Discussion
The benefit-risk of OFA for patients after operation is contradictory in previous studies, so further study is required. This trial will focus on the effect of OFA on the incidence of PONV in patients undergoing thoracoscopic surgery. This trial adopts uniformed PONV and perioperative pain management, standardised randomised and blind, clear-cut inclusion and exclusion criteria, and standardised scales to assess the severity of PONV after surgery, the quality of postoperative recovery, and the health status at 6 months. The findings of this study will help to provide references to promote early recovery of patients after lung surgery.
Trial registration
ClinicalTrials.gov NCT05411159. Registered on 9 June 2022.
Journal Article
A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation
by
Couto Irving, Susana S
,
Lomer, Miranda CE
,
Pereira, Dora IA
in
Abdominal Pain - chemically induced
,
Abdominal Pain - diagnosis
,
Administration, Oral
2014
Background
Oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects. The aim of this study was to develop and trial a short, simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating.
Methods
The study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out. Subjects were randomized into two treatment groups (n = 10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e. nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).
Results
Seventy five per cent of participants reporting the presence of one or more symptoms in the first week of the study were in the ferrous sulphate group. In the second week of the study (i.e. wash-out), 67% of the participants reporting one or more symptom(s) were in the ferrous sulphate group. In the first week of the study (treatment) the number of symptoms reported by participants in the ferrous sulphate group (mean ± SEM = 6.7 ± 1.7) was significantly higher than that for participants in the placebo group (1.2 ± 0.5) (
p
= 0.01). In the second week of the study (wash-out) the number of symptoms reported by participants in the ferrous sulphate group (4.6 ± 2.0) appeared higher than for participants in the placebo group (1.0 ± 0.7) although this did not reach significance (
p
= 0.12). Events for which the gastrointestinal symptom questionnaire was most discriminatory between ferrous sulphate and placebo groups were: heartburn, abdominal pain and the presence of black stools (all
p
≤ 0.03).
Conclusions
A tool for the detection of commonly-occurring side effects should not require large study numbers to be effective. With just 10 subjects per group (iron or placebo), this simple questionnaire measures gastrointestinal side-effects associated with oral iron (ferrous sulphate) supplementation, and would be appropriate for use in intervention studies or clinical trials.
Trial registration
ClinicalTrials.gov Identifier:
NCT02146053
(21/05/2014).
Journal Article
Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial
by
Martínez-St. John, Damian Robert James
,
Tomás-Rodríguez, María Isabel
,
Gil-Guillén, Vicente Francisco
in
692/1807/410/2610
,
692/700/565/411
,
Abdomen
2015
In 2014, we assessed the effectiveness of Medical Taping Concept (MTC) in Primary Dysmenorrhoea (PD) with a single-blind, two-armed clinical trial (NCT02114723, ClinicalTrials.gov) with a follow-up of 4 menstrual cycles (pre-intervention: 2 months; post-intervention: 2 months) in a sample formed by 129 Spanish women aged 18–30 years with PD. We had two groups: intervention group (75), MTC covering T-11 and T-12 dermatomes; control group (54), another taping in both greater trochanter areas. Our main outcome measures were: pre-intervention and post-intervention increase in pain difference measured 2 hours after commencement (
2-h pain
—
0-h pain
); difference between the number of tablets ingested post-intervention and pre-intervention; and associated symptoms in post-intervention (fatigue, vomiting, diarrhoea, nausea and others). Pain was assessed in: abdomen, legs, head and lower back. We found significant differences (p < 0.05) for number of tablets, abdominal and leg pain. In conclusion, the intervention group had less abdominal and leg pain when pharmacological therapy was not started. Furthermore, the intervention resulted in a lower intake of tablets. Nevertheless, more studies are needed to corroborate our results and to analyze the MTC effectiveness if women do not take any tablets during the entire menstrual period.
Journal Article
Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial
by
Wang, Huan
,
Xue, Na
,
Xu, Wei-ru
in
Acupuncture
,
Acupuncture Therapy - adverse effects
,
Acupuncture Therapy - methods
2017
Background
Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side effects in patients with cancer. The introduction and development of antiemetic drugs have significantly improved the ability of clinicians to control CINV, but it is not easy to translate to practical application, owing to financial issues, provider-related barriers, and patient factors. Nondrug therapies are needed to alleviate the symptoms of CINV. Acupuncture is an appropriate adjunctive treatment for CINV, but additional evidence is needed.
Methods/design
This study is a multicenter, randomized, sham-controlled prospective clinical trial. A total of 136 participants will be randomly allocated into the intervention group (verum acupuncture) or the control group (sham acupuncture) in a 1:1 ratio. All treatment will be given for 5 days. Participants in both groups will receive acupuncture sessions twice on the first day of chemotherapy and once consecutively on the following 4 days. Each session takes approximately 30 minutes. The primary outcome measure will be the Common Terminology Criteria for Adverse Events to assess CINV. The secondary outcome measures will be the Eastern Cooperative Oncology Group score, Simplified Nutritional Appetite Questionnaire, and Hospital Anxiety and Depression scale. Safety will be assessed at each visit.
Discussion
The results of this trial will provide clinical evidence for the effect and safety of acupuncture for CINV.
Trial registrations
ISRCTN Registry identifier:
ISRCTN13287728
). Registered on 28 February 2015.
ClinicalTrials.gov identifier:
NCT02369107
. Registered on 17 February 2015.
Journal Article
Evaluation of Ultrasound-guided Genitofemoral Nerve Block Combined with Ilioinguinal/iliohypogastric Nerve Block during Inguinal Hernia Repair in the Elderly
2019
To evaluate the anesthetic effect of ultrasound-guided (USG) ilioinguinal/iliohypogastric nerve (II/IHN) block combined with genital branch of genitofemoral nerve (GFN) block in the elderly undergoing inguinal hernia repair, 54 old patients (aged 60–96years, ASA I–III) with indirect hernia were enrolled and scheduled for unilateral tension-free herniorrhaphy. Patients were grouped randomly to receive either USG II/IHN plus GFN block (Group G) or USG II/IHN block alone (Group I). The intraoperative visual analogue scale (VAS) scores were recorded at skin incision, at spermatic cord/round ligament traction and at sac ligation. The resting and dynamic VAS scores were recorded postoperatively. The requirements of extra sedatives and analgesics for intra- and postoperative analgesia were assessed. Occurrence of complications of the block, postoperative nausea and vomiting and femoral nerve palsy was also reported. Both groups showed similar sensory block. When stretching spermatic cord/round ligament, the patients in group G had significantly lower VAS scores than in group I. And group G used much fewer adjuvant sedatives and analgesics to achieve adequate anaesthesia. In addition, group G was presented with better intraoperative anaesthesia and lower postoperative dynamic VAS scores at all time points tested. No significant difference was found in the postoperative requirement of rescue medication. Both groups showed no complications related to the block and group G reported no femoral nerve palsy. The addition of GFN block to II/IHN block improves the quality of perioperative anesthesia and analgesia in the elderly and reduces the consumption of extra sedatives and analgesics during the surgery.
Journal Article
Effects of Preoperative Serotonin-Receptor-Antagonist Administration in Spinal Anesthesia–Induced Hypotension: A Randomized, Double-Blind Comparison Study of Ramosetron and Ondansetron
by
Gwan-Woo, Lee
,
Eun-Su, Choi
,
Hyun-Jung, Shin
in
Bone surgery
,
Double-blind studies
,
Hypotension
2015
Background and ObjectivesThe adverse effects of spinal anesthesia (SA) include arterial hypotension and bradycardia. The aim of this study was to compare the effects of 2 type 3 serotonin receptor antagonists in SA-induced adverse effects. Specifically, we assessed whether ramosetron was more effective than ondansetron in reducing SA-induced decreases in blood pressure (BP) and heart rate (HR).MethodsA total of 117 patients undergoing orthopedic surgery and receiving SA were intravenously administered 0.3 mg of ramosetron (n = 39, group R), 4 mg of ondansetron (n = 39, group O4), or 8 mg of ondansetron (n = 39, group O8). Systolic BP (SBP), diastolic BP (DBP), mean BP (MBP), HR, and the lowest SBP, DBP, MBP, and HR values were measured preoperatively (baseline) and intraoperatively. The incidence of postoperative nausea and vomiting, the need for rescue antiemetics, the amount of patient-controlled analgesia consumption, and pain score in the first 48 hours after surgery were determined.ResultsBaseline values did not significantly differ among the 3 groups. After SA, SBP, DBP, MBP, and HR were lower than their baseline values in all 3 groups. The differences between the baseline and the lowest values were significantly less in group R than in groups O4 and O8 with respect to SBP (P < 0.001), DBP (P = 0.001), and MBP (P < 0.001) less in group R than in group O4 with respect to HR (P = 0.032). Intergroup differences were not significant for postoperative nausea and vomiting, the need for rescue antiemetics, patient-controlled analgesia consumption, or pain score.ConclusionsThe administration of ramosetron (0.3 mg) significantly attenuated the SA-induced decrease in BP compared with 4 or 8 mg of ondansetron and HR compared with 4 mg of ondansetron.
Journal Article
Cannabinoid Hyperemesis Syndrome: Diagnosis, Pathophysiology, and Treatment—a Systematic Review
by
Sorensen, Cecilia J.
,
Borgelt, Laura
,
Phillips, Kristina T.
in
Bathing
,
Baths
,
Biomedical and Life Sciences
2017
Cannabinoid hyperemesis syndrome (CHS) is a syndrome of cyclic vomiting associated with cannabis use. Our objective is to summarize the available evidence on CHS diagnosis, pathophysiology, and treatment. We performed a systematic review using MEDLINE, Ovid MEDLINE, Embase, Web of Science, and the Cochrane Library from January 2000 through September 24, 2015. Articles eligible for inclusion were evaluated using the Grading and Recommendations Assessment, Development, and Evaluation (GRADE) criteria. Data were abstracted from the articles and case reports and were combined in a cumulative synthesis. The frequency of identified diagnostic characteristics was calculated from the cumulative synthesis and evidence for pathophysiologic hypothesis as well as treatment options were evaluated using the GRADE criteria. The systematic search returned 2178 articles. After duplicates were removed, 1253 abstracts were reviewed and 183 were included. Fourteen diagnostic characteristics were identified, and the frequency of major characteristics was as follows: history of regular cannabis for any duration of time (100%), cyclic nausea and vomiting (100%), resolution of symptoms after stopping cannabis (96.8%), compulsive hot baths with symptom relief (92.3%), male predominance (72.9%), abdominal pain (85.1%), and at least weekly cannabis use (97.4%). The pathophysiology of CHS remains unclear with a dearth of research dedicated to investigating its underlying mechanism. Supportive care with intravenous fluids, dopamine antagonists, topical capsaicin cream, and avoidance of narcotic medications has shown some benefit in the acute setting. Cannabis cessation appears to be the best treatment. CHS is a cyclic vomiting syndrome, preceded by daily to weekly cannabis use, usually accompanied by symptom improvement with hot bathing, and resolution with cessation of cannabis. The pathophysiology underlying CHS is unclear. Cannabis cessation appears to be the best treatment
Journal Article