Clinical trial NCT06242262: Deep Neuromuscular Block With Low Pressure Pneumoperitoneum in Laparoscopic Abdominal Surgeries
Official title: Deep Neuromuscular Block With Low Pressure Pneumoperitoneum in Laparoscopic Abdominal Surgeries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Neuromuscular Block
Low Pressure
Pneumoperitoneum
Laparoscopic Abdominal Surgeries
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: The degree of pain
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Time of first analgesic
timeFrame: 48 hours postoperatively
measure: Total opioid consumption in 1st 48h
timeFrame: 48 hours postoperatively
measure: The degree of Patient satisfaction
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: