Clinical trial NCT03505255: Comparison Between Intraperitoneal Versus Intramuscular Neostigmine on Pattern of Postoperative GIT Motility in Patients Undergoing Laparoscopic Cholecystectomy
Official title: Comparison Between Intraperitoneal Versus Intramuscular Neostigmine on Pattern of Postoperative GIT Motility in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pattern of GIT Motility
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: passing flatus
timeFrame: each 2 hours
Secondary outcomes:
measure: Barium meal
timeFrame: after 4 hours, 24hours, 48 hours
Other outcomes:
Locations:
Study officials:
References:
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