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

April 12, 2018 updated by: Haitham Mohammad Ahmad Mohammad, Assiut University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A
Group A: 40 patients will receive intraperitoneal neostigmine 0.25 mg in 30 ml normal saline and 1 ml normal saline intramuscular.
Drug: Neostigmine
Neostigmine is a cholinesterase-inhibitor, which augments the concentration of acetylcholine (ACh) at the neuromuscular junction
ACTIVE_COMPARATOR: Group B
Group B: 40 patients will receive intraperitoneal neostigmine 0.5 mg in 30 ml normal saline and 1 ml normal saline intramuscular.
Drug: Neostigmine
Neostigmine is a cholinesterase-inhibitor, which augments the concentration of acetylcholine (ACh) at the neuromuscular junction
ACTIVE_COMPARATOR: Group C
Group C: 40 patients will receive intramuscular neostigmine 0.5 mg in 1 ml volume plus 30 ml normal saline intraperitoneal.
Drug: Neostigmine
Neostigmine is a cholinesterase-inhibitor, which augments the concentration of acetylcholine (ACh) at the neuromuscular junction
PLACEBO_COMPARATOR: Group D
Group D (control group): 40 patients will receive intraperitoneal 30 ml normal saline and 1 ml normal saline intramuscular.
Other: Normal saline
Normal saline 0.9 % is given in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
passing flatus
Time Frame: each 2 hours
A questionnaire for each patient about the first time to pass flatus or stool
each 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barium meal
Time Frame: 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.
after 4 hours, 24hours, 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (ACTUAL)

April 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIT motility after lap.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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