MedPath

Deep Neuromuscular Block With Low Pressure Pneumoperitoneum in Laparoscopic Abdominal Surgeries

Not Applicable
Completed
Conditions
Pneumoperitoneum
Laparoscopic Abdominal Surgeries
Deep Neuromuscular Block
Low Pressure
Interventions
Other: Moderate neuromuscular block
Other: Deep neuromuscular block
Registration Number
NCT06242262
Lead Sponsor
Tanta University
Brief Summary

The aim of this study is to evaluate the effect of deep neuromuscular block on postoperative pain, duration of surgery, quality of surgical field, length of recovery room stays, Total amount of rescue analgesic, postoperative nausea/vomiting, and length of hospital stay.

Detailed Description

Acute-pain management in surgery patients is accompanied by an array of negative consequences, including increased morbidity, impaired physical function, and quality of life, slowed recovery, prolonged opioid use during and after hospitalization, and increased cost of care.

Reducing pneumo-peritoneum (PP) is one technique for reducing postoperative pain. The effect of low PP on postoperative pain remains a controversial topic with other studies reporting no difference in postoperative pain levels between the Two pressures.

Deep neuromuscular block (DNMB) in abdominal surgeries is associated with various advantages, such as lower abdominal pressure, lower pain and rescue opioid consumption, as well as less bleeding. DNMB may facilitate the use of reduced insufflation pressure without compromising the surgical field of vision. However, its usage is limited due to a lack of predictable and rapid recovery with conventional NMB antagonists (neostigmine) or spontaneous recovery

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
44
Inclusion Criteria
  • Age 18 to 65 years old.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Patients scheduled for laparoscopic abdominal surgery.
Exclusion Criteria
  • Known allergies to cis-atracurium or neostigmine.
  • Contraindications to the use of neostigmine, such as bronchial asthma, glaucoma, myocardial ischemia, and epilepsy.
  • History of neuromuscular, renal, or hepatic disease; previous abdominal surgery.
  • Treatment with drugs known to affect neuromuscular function.
  • Preoperative hyperalgesia.
  • Peripheral neuropathy is caused by diabetes.
  • History of chronic analgesics treatment, drug, or alcohol abuse.
  • Body mass index (BMI) > 35 kg/m2.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Moderate neuromuscular blockModerate neuromuscular blockPatients will receive moderate neuromuscular block by using cis-atracurium.
Deep neuromuscular blockDeep neuromuscular blockPatients will receive deep neuromuscular block by using cis-atracurium
Primary Outcome Measures
NameTimeMethod
The degree of pain48 hours postoperatively

The degree of pain will be evaluated using the numerical rating scale (NRS) from (0 to 10), zero means no pain and ten means the worst pain. It will be measured at PACU, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.

Secondary Outcome Measures
NameTimeMethod
The degree of Patient satisfaction48 hours postoperatively

The degree of patient satisfaction will be assessed on a 5-point scale: (0= extremely dissatisfied, 1= unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied), 4= extremely satisfied).

Total opioid consumption in 1st 48h48 hours postoperatively

A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. If numerical rating scale (NRS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia.

Time of first analgesic48 hours postoperatively

Time of first analgesic will be measured from the end of surgery till first dose of morphine administrated. If numerical rating scale (NRS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia.

Trial Locations

Locations (1)

Tanta University

🇪🇬

Tanta, El-Gharbia, Egypt

© Copyright 2025. All Rights Reserved by MedPath