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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-10-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Pattern of GIT Motility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group A

Group A: 40 patients will receive intraperitoneal neostigmine 0.25 mg in 30 ml normal saline and 1 ml normal saline intramuscular.

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Neostigmine is a cholinesterase-inhibitor, which augments the concentration of acetylcholine (ACh) at the neuromuscular junction

Group B

Group B: 40 patients will receive intraperitoneal neostigmine 0.5 mg in 30 ml normal saline and 1 ml normal saline intramuscular.

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Neostigmine is a cholinesterase-inhibitor, which augments the concentration of acetylcholine (ACh) at the neuromuscular junction

Group C

Group C: 40 patients will receive intramuscular neostigmine 0.5 mg in 1 ml volume plus 30 ml normal saline intraperitoneal.

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Neostigmine is a cholinesterase-inhibitor, which augments the concentration of acetylcholine (ACh) at the neuromuscular junction

Group D

Group D (control group): 40 patients will receive intraperitoneal 30 ml normal saline and 1 ml normal saline intramuscular.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type OTHER

Normal saline 0.9 % is given in the control group

Interventions

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Neostigmine

Neostigmine is a cholinesterase-inhibitor, which augments the concentration of acetylcholine (ACh) at the neuromuscular junction

Intervention Type DRUG

Normal saline

Normal saline 0.9 % is given in the control group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No