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

A

Assiut University

Status and phase

Unknown
Phase 4

Conditions

Pattern of GIT Motility

Treatments

Other: Normal saline
Drug: Neostigmine

Study type

Interventional

Funder types

Other

Identifiers

NCT03505255
GIT motility after lap.

Details and patient eligibility

About

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

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

160 participants in 4 patient groups, including a placebo group

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

Trial contacts and locations

0

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Central trial contact

Ayman Ahmed Mamdouh, Associate Professor; Haitham Mohammad Ahmad Mohammad, Assistant lecturer

Data sourced from clinicaltrials.gov

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