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"Pneumoperitoneum, Artificial - methods"
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Low-pressure pneumoperitoneum with deep neuromuscular blockade versus standard pressure pneumoperitoneum in patients undergoing laparoscopic cholecystectomy for gallstone disease: a non-inferiority randomized control trial
by
Bansal, Virinder Kumar
,
Chumber, Sunil
,
Ranjan, Piyush
in
Clinical outcomes
,
Laparoscopy
,
Surgeons
2024
BackgroundLow-pressure pneumoperitoneum (LPP) is an attempt at improving laparoscopic surgery. However, it has the issue of poor working space for which deep neuromuscular blockade (NMB) may be a solution. There is a lack of literature comparing LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB.MethodologyThis was a single institutional prospective non-inferiority RCT, with permuted block randomization of subjects into group A and B [Group A: LPP; 8–10 mmHg with deep NMB [ Train of Four count (TOF): 0, Post Tetanic Count (PTC): 1–2] and Group B: SPP; 12–14 mmHg with moderate NMB]. The level of NMB was monitored with neuromuscular monitor with TOF count and PTC. Cisatracurium infusion was used for continuous deep NMB in group A. Primary outcome measures were the surgeon satisfaction score and the time for completion of the procedure. Secondarily important clinical outcomes were also reported.ResultsOf the 222 patients screened, 181 participants were enrolled [F: 138 (76.2%); M: 43 (23.8%); Group A n = 90, Group B n = 91]. Statistically similar surgeon satisfaction scores (26.1 ± 3.7 vs 26.4 ± 3.4; p = 0.52) and time for completion (55.2 ± 23.4 vs 52.5 ± 24.9 min; p = 0.46) were noted respectively in groups A and B. On both intention-to-treat and per-protocol analysis it was found that group A was non-inferior to group B in terms of total surgeon satisfaction score, however, non-inferiority was not proven for time for completion of surgery. Mean pain scores and incidence of shoulder pain were statistically similar up-to 7 days of follow-up in both groups. 4 (4.4%) patients in group B and 2 (2.2%) in group A had bradycardia (p = 0.4). Four (4.4%) cases of group A were converted to group B. One case of group B converted to open surgery. Bile spills and gallbladder perforations were comparable.ConclusionLPP with deep NMB is non-inferior to SPP with moderate NMB in terms of surgeon satisfaction score but not in terms of time required to complete the procedure. Clinical outcomes and safety profile are similar in both groups. However, it could be marginally costlier to use LPP with deep NMB.
Journal Article
Randomized Clinical Trial of Moderate Versus Deep Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy
by
Yoon, Yoo-Seok
,
Seo, Kwang-Suk
,
Koo, Bon-Wook
in
Abdominal Surgery
,
Adductor Pollicis Muscle
,
Adult
2016
Background
The beneficial effects of deep blockade are not fully known. In this study, we evaluated the effect of deep neuromuscular blockade on surgical conditions during laparoscopic cholecystectomy under low-pressure pneumoperitoneum.
Methods
Patients undergoing elective laparoscopic cholecystectomy were randomized to either the moderate group (train-of-four count of 1 or 2) or deep group (posttetanic count of 1 or 2). Neuromuscular blockade was induced and maintained with rocuronium; it was reversed with sugammadex in the deep group and with neostigmine in the moderate group. At the beginning of surgery, the intra-abdominal pressure was set at 8 mmHg. The surgeon rated the surgical condition on a 4-point scale (1 = excellent, 2 = good, 3 = acceptable, 4 = poor) and was allowed to increase the pressure to 12 mmHg if it was determined that the surgical conditions were inadequate for the operation.
Results
A total of 64 patients completed the study. The rate of increasing intra-abdominal pressure to maintain optimal surgical conditions was 34.4 % in the moderate group and 12.5 % in the deep group (
P
= 0.039). The proportion of patients with a surgical condition score of 1 or 2 (excellent or good) was 34.4 % in the moderate group and 68.8 % in the deep group (
P
= 0.006).
Conclusion
The maintenance of intraoperative deep neuromuscular blockade was associated with a lower rate of conversion to standard pressure and higher surgeon satisfaction with the surgical conditions than was moderate blockade in patients undergoing low-pressure pneumoperitoneum laparoscopic cholecystectomy.
Journal Article
Comparison of inflammatory markers in low-pressure pneumoperitoneum with deep neuromuscular block versus standard pressure pneumoperitoneum among patients undergoing laparoscopic cholecystectomy for gallstone disease: a randomized control trial
by
Chumber, Sunil
,
Ranjan, Piyush
,
Asuri, Krishna
in
Cholecystectomy
,
Clinical trials
,
Gallstones
2024
BackgroundLow-pressure pneumoperitoneum (LPP) is an attempt to improve laparoscopic surgery. Lower pressure causes lesser inflammation and better hemodynamics. There is a lack of literature comparing inflammatory markers in LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB in laparoscopic cholecystectomy.MethodologyThis was a single institutional prospective randomized control trial. Participants included all patients undergoing laparoscopic cholecystectomy for symptomatic gall stone disease. Participants were divided into 2 groups group A and B. Group A—Low-pressure group in which pneumoperitoneum pressure was kept low (8–10 mmHg) with deep Neuromuscular blockade (NMB) and Group B—Normal pressure group (12–14 mmHg) with moderate NMB. A convenience sample size of 80 with 40 in each group was selected. Lab investigations like CBC, LFT, RFT and serum IL-1, IL-6, IL-17, TNF alpha levels were measured at base line and 24 h after surgery and compared using appropriate statistical tests. Other parameters like length of hospital stay, post-operative pain score, conversion rate (low-pressure to standard pressure), and complications were also compared.ResultsEighty participants were analysed with 40 in each group. Baseline characteristics and investigations were statistically similar. Difference (post-operative–pre-operative) of inflammatory markers were compared between both groups. Numerically there was a slightly higher rise in most of the inflammatory markers (TLC, ESR, CRP, IL-6, TNFα) in Group B compared to Group A but not statistically significant. Albumin showed significant fall (p < 0.001) in Group B compared to Group A. Post-operative pain was also significantly less (p < 0.001) in Group A compared to Group B at 6 h and 24 h. There were no differences in length of hospital stay and incidence of complications. There was no conversion from low-pressure to standard pressure.ConclusionLaparoscopic cholecystectomy performed under low-pressure pneumoperitoneum with deep NMB may have lesser inflammation and lesser post-operative pain compared to standard pressure pneumoperitoneum with moderate NMB. Future studies with larger sample size need to be designed to support these findings.
Journal Article
The impact of low pressure pneumoperitoneum in robotic assisted radical prostatectomy II: a prospective, randomized, double blinded trial
by
Holdren, Charla
,
Pulford, Christopher
,
Keating, Kevin
in
Aged
,
Blood Loss, Surgical
,
Complications
2024
Objective
To analyze postoperative ileus rates and postoperative complications between the different pneumoperitoneum settings. The secondary objective was to evaluate narcotic use and intraoperative blood loss between the different pneumoperitoneum settings.
Methods
A prospective, randomized, double blinded study was conducted at pneumoperitoneum pressures of either 12 mmHg or 15 mmHg for patients undergoing robotic assisted radical prostatectomy with bilateral pelvic lymph node dissection by a single high volume surgeon.
Results
The risk of ileus in the 12 mmHg group was 1.9% (2/105) compared to 3.2% (3/93) in the 15 mmHg group (OR 0.58, 95%CI 0.1−3.6). There was no difference in the risk of any complication with a complication rate of 4.8% (5/105) in the 12 mmHg arm compared to 4.3% (4/93) in the 15 mmHg arm (OR 1.1, 95% CI 0.3 – 4.3).
Conclusion
Pneumoperitoneum pressure setting of 12 mmHg has no significant difference to 15 mmHg in the rate of postoperative complications, narcotic use, and intraoperative bleeding. Additional research is warranted to understand the optimal.
Journal Article
High versus low pneumoperitoneum PressUre for parenchymal transection in minimally invasive major liver surgery (PPULS)—a non-inferiority, multicenter, randomized, controlled trial
by
D’Hondt, Mathieu
,
Michalski, Christoph
,
Rahbari, Nuh
in
Adult
,
Biomedicine
,
Blood Loss, Surgical - prevention & control
2025
Background
Low pneumoperitoneum pressure (LPP) lowers the incidence of CO
2
embolisms in minimally invasive liver resections (MILR), while higher pneumoperitoneum pressure (HPP) reduces intraoperative blood loss. This contradiction necessitates careful pressure management especially in major liver resections where intraoperative blood loss greatly impacts postoperative outcome.
Methods
In this randomized non-inferiority trial, adults undergoing elective MILR for any indication will be recruited in alignment with inclusion and exclusion criteria. After given informed consent, eligible patients will be randomized to either low (≤10 mmHg) or high (≥14 mmHg) pneumoperitoneum pressure during parenchymal transection. Blood, peritoneal biopsies, and liver tissue will be sampled to evaluate intraoperative tissue damage. Sample size (
n
= 66 patients per group) is calculated based on the current literature. The primary study endpoint is intraoperative blood loss during the parenchymal transection phase. Secondary endpoints include CO
2
embolisms, intraoperative tissue damage, operation time, morbidity, mortality, and duration of hospitalization.
Discussion
Minimizing intraoperative blood loss in MILR is a clinically relevant problem, which greatly impacts the procedure’s safety and influences the patient’s morbidity and mortality. HPP, exerting counter pressure to the vascular pressure, serves for bleeding control in MILR. The risk of CO
2
embolism, arising from the combination of high intra-abdominal pressure and low central venous pressure, favors the use of LPP. The proposed trial aims to assess the non-inferiority of LPP compared to HPP during the parenchymal transection phase of MILR.
Trial registration
ClinicalTrials.gov NCT06770803. First Submitted: 2024-12-30, First Submitted that Met QC Criteria: 2025-01-07, First Posted: 2025-01-13.
Journal Article
Impact of standard-pressure and low-pressure pneumoperitoneum on shoulder pain following laparoscopic cholecystectomy: a randomised controlled trial
2017
Background
The incidence of shoulder pain (SP) following laparoscopic cholecystectomy (LC) varies between 21 and 80 %. A few randomised controlled trials and meta-analysis have shown lesser SP in LC performed under low-pressure carbon dioxide pneumoperitoneum (LPCP) than under standard-pressure carbon dioxide pneumoperitoneum (SPCP). However, the possible compromise in adequate exposure and effective working space during LPCP has negatively influenced its uniform adoption for LC.
Materials and methods
All consecutive patients undergoing elective LC for gallstone disease who met the inclusion and exclusion criteria were enroled. Fourty patients were randomised to SPCP group (pressure of 14 mmHg) and 40 to LPCP group (pressure of 9–10 mmHg). Primary outcome measured was incidence of SP and its severity on visual analogue scale (VAS) at 4, 8, 24 h and 7 days after LC. Secondary outcomes measured were procedural time, technical difficulty, surgeons’ satisfaction score on exposure and working space, intra-operative changes in heart rate and blood pressure, abdominal pain and analgesic requirement. Analyses were performed using Stata software.
Results
There was no conversion to open surgery, bile duct injury or need to increase intra-abdominal pressure on either group. Twenty-three patients (57.5 %) in SPCP group and nine patients (22.5 %) in LPCP group had SP (
p
= 0.001). The severity of SP was significantly more in SPCP group at 8 and 24 h (
p
= 0.009 and 0.005, respectively). Both the groups had similar procedural time, surgeons’ satisfaction score, intra-operative changes in heart rate and blood pressure.
Conclusion
The incidence and severity of SP following LC performed at LPCP are significantly less compared to that in SPCP. The safety, efficacy and surgeons’ satisfaction appear to be comparable in both the groups. Hence, a routine practice of low-pressure carbon dioxide pneumoperitoneum may be recommended in selected group of patients undergoing laparoscopic cholecystectomy.
Clinical trial registration number
CTRI/2016/02/006590.
Journal Article
Randomized controlled trial comparing low pressure (8 mmHg) versus high pressure (14 mmHg) CO2 insufflation on postoperative pain in patients undergoing laparoscopic cholecystectomy: Protocol
2025
Laparoscopic cholecystectomy is the gold standard for treating symptomatic gallstone disease. Pneumoperitoneum is essential for adequate visualization during the procedure and is typically maintained at a standard pressure of 12-14 mmHg. However, high insufflation pressure may contribute to increased postoperative pain. This study aims to assess whether low-pressure pneumoperitoneum (8 mmHg) reduces postoperative pain compared to standard pressure (14 mmHg), without compromising operative safety or efficacy. We hypothesize that low pressure pneumoperitoneum at 8 mmHg reduces postoperative pain, without increasing operation time or postoperative morbidity.
This is a single-center, randomized, controlled, double-blind trial. Consecutive Adult patients scheduled for elective laparoscopic cholecystectomy will be randomized in a 1:1 ratio to receive either low-pressure (8 mmHg) or standard-pressure (14 mmHg) pneumoperitoneum. The primary outcome is postoperative abdominal pain assessed using the Visual Analog Scale (VAS) at 6 hours after surgery. Secondary outcomes include VAS pain scores at 12 and 24 hours, postoperative nausea and/or vomiting, postoperative hospital stay and postoperative 30-day morbidity. The enrollment of patients will be done between November 12, 2024 to December 31, 2025.
ClinicalTrials.gov NCT06685250.
If proven effective, low-pressure pneumoperitoneum may represent a simple strategy to improve postoperative comfort in laparoscopic cholecystectomy without compromising surgical outcomes.
Journal Article
The impact of low pressure pneumoperitoneum in robotic assisted radical prostatectomy: a prospective, randomized, double blinded trial
by
Maatman, Thomas J
,
Rohloff, Matthew
,
Shakuri-Rad Jaschar
in
Cancer surgery
,
Patients
,
Pressure
2021
BackgroundRobotic surgery has revolutionized postoperative outcomes across surgical specialties. However, the use of pneumoperitoneum comes with known risks given the change in physiological parameters that accompany its utilization. A recent internal review found a 7% decrease in postoperative ileus rates when utilizing a pneumoperitoneum of 12 mmHg over the standard 15 mmHg in robotic assisted radical prostatectomies (RARP).ObjectiveThe purpose of this study is to prospectively evaluate the utility of lower pressure pneumoperitoneum by comparing 8 mmHg and 12 mmHg during RARP.Design, setting and partcipantsPatients were randomly assigned to undergo robotic assisted radical prostatectomy at a pneumoperitoneum pressure of 12 mmHg or 8 mmHg.Outcome measurements and statistical analysisThe primary outcome was development of postoperative ileus and secondary outcomes were length of operation, estimated blood loss and positive surgical margin status.Results and limitationsA total of 201 patients were analyzed; 96 patients at 8 mmHg and 105 patients at 12 mmHg. The groups were adequately matched as there were no differences between demographic parameters or medical comorbidities. There was a decrease in postoperative ileus rates with lower pneumoperitoneum pressures; 2% at 8 mmHg and 4.8% at 12 mmHg. There were no clinically significant differences in estimated blood loss, total length of operative time and positive margin status.ConclusionsLower pressure pneumoperitoneum during robotic assisted radical prostatectomy is non-inferior to higher pressure pneumoperitoneum levels and the experienced surgeon may safely perform this operation at 8 mmHg to take advantage of the proposed benefits.
Journal Article
Effects of intraoperative protective lung ventilation on postoperative pulmonary complications in patients with laparoscopic surgery: prospective, randomized and controlled trial
2016
Background
Respiratory functions are usually impaired during pneumoperitoneum for laparoscopic surgery. This randomized, controlled and single-blinded study was performed to evaluate whether intraoperative protective lung ventilation influences postoperative pulmonary complications after laparoscopic hepatobiliary surgery.
Methods
Sixty-two patients were randomized to receive either conventional ventilation with alveolar recruitment maneuver (tidal volume of 10 ml/kg with inspiratory pressure of 40 cmH
2
O for 30 s after the end of pneumoperitoneum, group R), or protective lung ventilation (low tidal volume of 6 ml/kg with positive end-expiratory pressure [PEEP] of 5 cmH
2
O, group P). Induction and maintenance of anesthesia were done with balanced anesthesia. Respiratory complications such as atelectasis, pneumonia or desaturation were observed postoperatively. The length of hospital stay, arterial blood gas analysis, peak inspiratory pressure and hemodynamic variables were also recorded. Results are presented as mean ± SD or number of patients (%).
Results
Postoperative pulmonary complications (
P
= 0.023) and desaturation below 90 % (
P
= 0.016) occurred less frequently in group P than in group R. Eight patients of group R and 3 patients of group P showed atelectasis. Pneumonia was diagnosed in 1 patient of group R. No differences were observed in the length of hospital stay, arterial blood gas analysis (pH, PaO
2
, PaCO
2
and PAO
2
) and hemodynamic variables except PAO
2
, AaDO
2
and peak inspiratory pressure between the two groups.
Conclusion
Protective lung ventilation (low tidal volume with PEEP) during pneumoperitoneum was associated with less incidences of pulmonary complications than conventional ventilation with alveolar recruitment maneuver after laparoscopic hepatobiliary surgery.
Journal Article
Randomized control trial on effectiveness and safety of direct trocar versus Veress needle entry techniques in obese women during diagnostic laparoscopy
by
Eleje, George U.
,
Okoro, Chukwuemeka C.
,
Okpala, Boniface Chukwuneme
in
Abdomen
,
Adult
,
Body mass index
2021
Purpose
To determine the benefits and safety of direct trocar insertion versus Veress needle technique in obese women undertaking diagnostic laparoscopy procedures.
Methods
Randomized-controlled trial on 135 obese women undergoing diagnostic laparoscopy and dye test for infertility was conducted. Women were randomly assigned to either direct trocar access (
n
= 68) or Veress needle access (
n
= 67) before achieving pneumoperitoneum. The same surgeon executed the laparoscopic techniques with a single-puncture technique. The primary outcome measures included total length of the procedure and incidence of any complications, while the mean laparoscopic entry time, volume of CO
2
required, and total of tries needed to attain successful entry were secondary outcomes. Intention-to-treat principle was applied to analysis.
Results
Women in both groups had similar socio-demographic and clinical characteristics and none were lost to follow-up. The overall length of the procedure was significantly lesser in the direct trocar group compared to the Veress needle group (9.9 ± 6.0 vs 16.7 ± 4.7 min;
p
< 0.001). No significant differences occurred in other outcomes including mean entry time, volume of CO
2
used, number of attempts for successful entry, and major/minor complications (
p
> 0.05).
Conclusions
Direct trocar technique may be an effective alternative to Veress needle for pneumoperitoneum in obese women for diagnostic laparoscopy. It has a comparable rapid laparoscopic entry time but a significantly lower duration of the procedure and shorter exposure to anesthesia. Both methods are equally effective as there was no significant difference in the complications recorded. A greater sample trial may be essential for more corroborative substantiation.
Clinical trial registration: PACTR201510000999192.
Journal Article