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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02607488
Date of registration:	15/11/2015
Prospective Registration:	Yes
Primary sponsor:	Mansoura University
Public title:	Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Bariatric Surgery
Scientific title:	Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Laparoscopic Bariatric Surgery: A Dose Dependent Study
Date of first enrolment:	November 2020
Target sample size:	180
Recruitment status:	Suspended
URL:	https://clinicaltrials.gov/show/NCT02607488
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 1/Phase 2

Countries of recruitment
Egypt

Contacts

Name:	Samah El Kenany, MD
Address:
Telephone:
Email:
Affiliation:	Department of Anaesthesia and Surgical Intensive Care, College of Medicine, Mansoura University, Egypt

Name:	Mohamed R El Tahan, MD
Address:
Telephone:
Email:
Affiliation:	Departments of Anaesthesia and Surgical Intensive Care, College of Medicine, Mansoura University, Egypt, and Anesthesiology Department, College of Medicine, University of Dammam, Saudi Arabia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Obese patients with a body mass index equal or greater than 35 kg/m2.

- American Society of Anesthesiologists (ASA) II-III

- Patients scheduled for laparoscopic bariatric surgery under general anesthesia

Exclusion Criteria:

- History of significant cardiac disease.

- History of significant respiratory disease.

- History of significant hepatic disease.

- History of significant renal diseases.

- History of an atrio-ventricular block grade II to III.

- Long QT syndrome.

- Pre-existing disorder of the gastrointestinal tract.

- Patients with history of alcohol or drug abuse.

- Allergy to amide local anesthetics.

- History of epilepsy.

- Pregnancy.

- Patients receiving cardiovascular medications.

- Patients receiving steroids.

- Patients receiving an opioid analgesic medication within 24 h before the operation.

- Conversion from a laparoscopic to an open laparotomy.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Bariatric Surgery Candidate

Intervention(s)

Drug: Lidocaine 2%

Drug: Lidocaine 1%

Drug: Lidocaine 1.5%

Drug: Placebo

Primary Outcome(s)

Postoperative recovery of bowel function [Time Frame: For 72 hours after surgery]

Secondary Outcome(s)

Intraoperative total use of fentanyl [Time Frame: For 4 hours after induction of anaesthesia]

Length of Post-Anaesthesia Care Unit stay [Time Frame: For 4 hours after surgery]

Number of participants with lidocaine treatment-related adverse events [Time Frame: For 48 hours after surgery]

Overall patient satisfaction score [Time Frame: For 48 hours after surgery]

Postoperative pruritus [Time Frame: For 48 hours after surgery]

Times to clinical recovery [Time Frame: For 2 hours after surgery]

Associated comorbidities [Time Frame: For 1 day before induction of anaesthesia]

Postoperative cumulative morphine use [Time Frame: For 48 hours after surgery]

The balance between the fluid intake and output [Time Frame: For 48 hours after surgery]

Time to actual discharge from hospital [Time Frame: For 10 days after surgery]

Perioperative changes in heart rate [Time Frame: For 48 hours after surgery]

Number of participants with surgery-related complications [Time Frame: For 15 days after surgery]

Perioperative changes in cognitive function [Time Frame: For 48 hours after surgery]

Perioperative use of norepinephrine [Time Frame: For 48 hours after surgery]

Serum lidocaine level [Time Frame: For 48 hours after surgery]

Pain scores [Time Frame: For 48 hours after surgery]

Plasma albumin level [Time Frame: For 48 hours after surgery]

Perioperative use of dobutamine [Time Frame: For 48 hours after surgery]

Postoperative sedation [Time Frame: For 48 hours after surgery]

Perioperative changes in blood pressure [Time Frame: For 48 hours after surgery]

Perioperative use of intravenous fluids [Time Frame: For 48 hours after surgery]

Postoperative nausea and vomiting [Time Frame: For 48 hours after surgery]

Time to readiness for hospital [Time Frame: for 10 days after surgery]

Secondary ID(s)

R-15-10-47

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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