Deep Neuromuscular Block With Low Pressure Pneumoperitoneum in Laparoscopic Abdominal Surgeries

NCT06242262 | Completed

• 1 other identifier: 36264PR461/12/2023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Neuromuscular Block; Low Pressure; Pneumoperitoneum; Laparoscopic Abdominal Surgeries

Outcome Measures

Primary Outcomes (1)

• The degree of pain

  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.

  48 hours postoperatively

Secondary Outcomes (3)

• Time of first analgesic

  48 hours postoperatively

• Total opioid consumption in 1st 48h

  48 hours postoperatively

• The degree of Patient satisfaction

  48 hours postoperatively

Study Arms (2)

Deep neuromuscular block

EXPERIMENTAL

Patients will receive deep neuromuscular block by using cis-atracurium

Other: Deep neuromuscular block

Moderate neuromuscular block

OTHER

Patients will receive moderate neuromuscular block by using cis-atracurium.

Other: Moderate neuromuscular block

Interventions

Moderate neuromuscular block OTHER

Patients will receive moderate neuromuscular block by using cis-atracurium. Pump delivery of cis-atracurium will be started when the TOF count returned to 2. The TOF count is maintained between 1 and 3 by adjusting the pump rate

Moderate neuromuscular block

Deep neuromuscular block OTHER

Patients will receive deep neuromuscular block by using cis-atracurium. After tracheal intubation for 15 min, a cis-atracurium pump will be started, and its rate will be adjusted to maintain a post-tetanic count (PTC) in the 1-2 range.

Deep neuromuscular block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years old.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Patients scheduled for laparoscopic abdominal surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 5, 2024
• Study Start: October 3, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)