Comparison Between Intraperitoneal Versus Intramuscular Neostigmine on Pattern of Postoperative GIT Motility in Patients Undergoing Laparoscopic Cholecystectomy

Phase 4

• Conditions: Pattern of GIT Motility
• Interventions: Drug: Neostigmine; Other: Normal saline

• Registration Number: NCT03505255
• Lead Sponsor: Assiut University

Brief Summary

The goal in this work is to compare between the effects of intraperitoneal versus intramuscular neostigmine on pattern of postoperative GIT motility in patients undergoing laparoscopic cholecystectomy

Detailed Description

Despite numerous advances in surgical technique and perioperative care, postoperative ileus (POI) continues to be one of the most common and expected aspects of abdominal surgery. It prolongs hospital stays, increases medical costs and frustrates patients and surgeons.

Many authors suggest that POI is a mandatory phase of the recovery period for any intra-abdominal procedure, and only an ileus lasting greater than 5 days is abnormal - to be termed a prolonged POI.

Under this definition, fully 40% of patients undergoing laparotomy experience prolonged postoperative ileus.

In 2006, different types of postoperative ileus (primary, secondary, recurrent, prolonged) were defined through consensus, and prolonged postoperative ileus was defined as absence of bowel function after the third postoperative day for laparoscopic surgery and after the fifth postoperative day for open abdominal surgery.

What constitutes prolonged postoperative ileus is debated, with many different definitions reported; consequently reported incidences range from 3% to 32%. Neostigmine is a cholinesterase-inhibitor, which augments the concentration of acetylcholine (ACh) at the neuromuscular junction, thereby increasing contractions in the normal gut.

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-12
• Last Update Submitted: 2018-04-12
• Study First Posted: 2018-04-23
• Last Update Posted: 2018-04-23
• Study Start: 2018-09-01
• Primary Completion: 2020-09
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

ASA status I and II patients, aged between 20 and 60 years, who are scheduled for laparoscopic cholecystectomy.

Exclusion Criteria

Patients with electrolyte imbalance Patients with diabetes mellitus Patients who are addict to opioids Patients with neurological defects or paralysis or preoperative recumbence. Patients with atrial-ventricular conduction disturbances, sinus bradycardia < 60 BPM or a nodal rhythm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Neostigmine	Group C: 40 patients will receive intramuscular neostigmine 0.5 mg in 1 ml volume plus 30 ml normal saline intraperitoneal.
Group A	Neostigmine	Group A: 40 patients will receive intraperitoneal neostigmine 0.25 mg in 30 ml normal saline and 1 ml normal saline intramuscular.
Group D	Normal saline	Group D (control group): 40 patients will receive intraperitoneal 30 ml normal saline and 1 ml normal saline intramuscular.
Group B	Neostigmine	Group B: 40 patients will receive intraperitoneal neostigmine 0.5 mg in 30 ml normal saline and 1 ml normal saline intramuscular.

Primary Outcome Measures

Name	Time	Method
passing flatus	each 2 hours	A questionnaire for each patient about the first time to pass flatus or stool

Secondary Outcome Measures

Name	Time	Method
Barium meal	after 4 hours, 24hours, 48 hours	Upon regaining consciousness in the recovery room after operation, the patient will be asked to swallow another 30 cc. of liquid barium and 4 hours later abdominal roentgenogram film will be taken.