Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTanta University
About this trial
This prospective randomized non-inferiority study will be conducted to compare the analgesic anti-emetic effects of intravenous ondansetron versus perineural ondansetron in patients undergoing laparoscopic sleeve gastrectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of either sex
American Society Anesthesiologists physical (ASA) status II-III
age between 18-65 years old
Body mass index (BMI) >35 kg/m2 with comorbidity or > 40 kg/m2 -- undergoing laparoscopic sleeve gastrectomy with intraoperative surgeon performed laparoscopic paragastric autonomic neural blockade..
Disqualifiers
Allergy to experimental drugs.
Known to have long QT, previous history of postoperative nausea and vomiting
Abuse of alcohol, analgesia, or sedative antidepressant drugs
Chronic pain disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Perineural ondansetron
DrugPara-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml (4 mg) ondansetron. At the same time, 15 ml saline will be injected slowly IV over 15 minutes.
Intravenous ondansetron
DrugPara-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml saline. At the same time, 4 mg (2 ml) ondansetron mixed with 13 ml saline (total 15 ml) will be slowly injected IV over 15 minutes.
Treatment groups
482 Participants
are divided into 2 treatment groupsGroup A: Perineural ondansetron groupExperimental treatment 1 intervention
Group B: Intravenous ondansetron groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of vomiting in the early 8 hours after surgery.
Any attack of vomiting will be recorded for all patients.
Time frame
8 hours after surgery.2
Degree of postoperative pain at 1 hour after surgery as measured by the numerical rating scale pain score.
Numerical rating scale pain score (NRS) ranges from 0 = no pain to 10= worst pain.
Time frame
1 hour after surgery.Secondary outcomes
1
Incidence of postoperative nausea and vomiting at 1 h, 8 h, and at 24 hours after surgery.
Any attack of nausea and vomiting will be recorded for all patients. Numerical rating scale from 0 (no nausea) to 10 (worst nausea) will be used to assess the severity of nausea.
Time frame
24 hours after surgery.2
Number of rescue anti-emetic doses in the first postoperative day.
Routine anti-emetics will be given every 8 hours in the form of IV metoclopramide 10 mg. Rescue anti-emetic medication in the form of ondansetron 8 mg slowly IV will be given. The total required dose and number of ondansetron boluses will be recorded.
Time frame
24 hours after surgery.3
Postoperative pain scores at 4 h, 8 h, and 24 hour after surgery.
Numerical rating scale pain score (NRS) ranges from 0 = no pain to 10= worst pain will be used to evaluate pain scores after surgery.
Time frame
24 hours after surgery.4
Time to first rescue opioid analgesic.
opioid dose will be given to patients with pain score ≥ 4.
Time frame
24 hours after surgery.Sponsors and contacts
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Source ClinicalTrials.gov