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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03505255
Enrollment
160
Registered
2018-04-23
Start date
2018-09-01
Completion date
2020-10-31
Last updated
2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pattern of GIT Motility

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.

Interventions

DRUGNeostigmine

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

OTHERNormal saline

Normal saline 0.9 % is given in the control group

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
passing flatuseach 2 hoursA questionnaire for each patient about the first time to pass flatus or stool

Secondary

MeasureTime frameDescription
Barium mealafter 4 hours, 24hours, 48 hoursUpon 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.

Contacts

Primary ContactHaitham Mohammad Ahmad Mohammad, Assistant lecturer
hythemmoh@yahoo.com01067330721
Backup ContactAyman Ahmed Mamdouh, Associate Professor
aymanosman2000@yahoo.com01066066001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026