NCT03505255

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2018

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

April 5, 2018

Last Update Submit

April 12, 2018

Conditions

Pattern of GIT Motility

Outcome Measures

Primary Outcomes (1)

  • passing flatus

    A questionnaire for each patient about the first time to pass flatus or stool

    each 2 hours

Secondary Outcomes (1)

  • Barium meal

    after 4 hours, 24hours, 48 hours

Study Arms (4)

Group A

ACTIVE COMPARATOR

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

Drug: Neostigmine

Group B

ACTIVE COMPARATOR

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

Drug: Neostigmine

Group C

ACTIVE COMPARATOR

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

Drug: Neostigmine

Group D

PLACEBO COMPARATOR

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

Other: Normal saline

Interventions

NeostigmineDRUG

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

Group AGroup BGroup C
Normal salineOTHER

Normal saline 0.9 % is given in the control group

Group D

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Baig MK, Wexner SD. Postoperative ileus: a review. Dis Colon Rectum. 2004 Apr;47(4):516-26. doi: 10.1007/s10350-003-0067-9. Epub 2004 Feb 25.

    PMID: 14978625BACKGROUND

  • Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007 Mar;245(3):355-63. doi: 10.1097/01.sla.0000232538.72458.93.

    PMID: 17435541BACKGROUND

  • Schuster R, Grewal N, Greaney GC, Waxman K. Gum chewing reduces ileus after elective open sigmoid colectomy. Arch Surg. 2006 Feb;141(2):174-6. doi: 10.1001/archsurg.141.2.174.

    PMID: 16490895BACKGROUND

  • Sajja SB, Schein M. Early postoperative small bowel obstruction. Br J Surg. 2004 Jun;91(6):683-91. doi: 10.1002/bjs.4589.

    PMID: 15164435BACKGROUND

  • Viscusi ER, Goldstein S, Witkowski T, Andonakakis A, Jan R, Gabriel K, Du W, Techner L, Wallin B. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study. Surg Endosc. 2006 Jan;20(1):64-70. doi: 10.1007/s00464-005-0104-y. Epub 2005 Dec 7.

    PMID: 16333556BACKGROUND

  • Husebye E. Gastrointestinal motility disorders and bacterial overgrowth. J Intern Med. 1995 Apr;237(4):419-27. doi: 10.1111/j.1365-2796.1995.tb01196.x.

    PMID: 7714466BACKGROUND

  • Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.

    PMID: 11091234BACKGROUND

  • Goyal RK, Hirano I. The enteric nervous system. N Engl J Med. 1996 Apr 25;334(17):1106-15. doi: 10.1056/NEJM199604253341707. No abstract available.

    PMID: 8598871BACKGROUND

MeSH Terms

Interventions

NeostigmineSaline Solution

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Haitham Mohammad Ahmad Mohammad, Assistant lecturer

CONTACT

01067330721hythemmoh@yahoo.com

Ayman Ahmed Mamdouh, Associate Professor

CONTACT

01066066001aymanosman2000@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 23, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

April 23, 2018

Record last verified: 2018-04