Deep Neuromuscular Block With Low Pressure Pneumoperitoneum in Laparoscopic Abdominal Surgeries

NCT ID: NCT06242262

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2024-03-01

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Deep neuromuscular block

Patients will receive deep neuromuscular block by using cis-atracurium

Group Type: EXPERIMENTAL

Deep neuromuscular block

Intervention Type: 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.

Moderate neuromuscular block

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

Group Type: OTHER

Moderate neuromuscular block

Intervention Type: 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

Interventions

Deep neuromuscular block

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.

Intervention Type: OTHER

Moderate neuromuscular block

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

ِAhmed Mohamed Ibrahim

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264PR461/12/2023

Identifier Type: -

Identifier Source: org_study_id