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Efficacy of combining Cyclizine, Metoclopramide or Ondansetron with Dexamethasone in prevention of Postoperative Nausea and Vomiting after Laparoscopic Sleeve Gastrectomy; A randomized controlled trial

Efficacy of combining Cyclizine, Metoclopramide or Ondansetron with Dexamethasone in prevention of Postoperative Nausea and Vomiting after Laparoscopic Sleeve Gastrectomy; A randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202303703098345
Enrollment
210
Registered
2023-03-01
Start date
2022-11-09
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Digestive System Surgery

Interventions

Sponsors

Kasr alainy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Age (18 – 65). ? Both gender ? Body mass index (BMI) 40 to 50 kg/m2 ? American Society of Anesthesiologist (ASA) - physical status III. ? Patients undergoing laparoscopic sleeve gastrectomy surgery under general anesthesia.

Exclusion criteria

Exclusion criteria: ? Patient refusal. ? Patients with known sensitivity or contraindication to drugs used in the study: ? Cyclizing (Closed angle glaucoma, Enlarged prostate and Urinary bladder complete or incomplete blockage). ? Metoclopramide (History of extrapyramidal disorders, Epilepsy, Parkinson's disease, mental illness and Intestinal obstruction). ? Ondansetron (Agitation , Intestinal obstruction and Severe electrolytes imbalance ) ? Patients on steroids ( Immunosuppressant’s and Cancer therapy ) ? Patients on antiemetics.( Motion sickness , Severe cases of gastroenteritis and Other infections ) ? Patients on chronic opioid therapy ( Patients with malignancy ). ? Severe respiratory or cardiac disorders ( Bronchial asthma , laryngeal oedema , stridor , Respiratory failure , Heart failure, Arrhythmias and Patients with a pacemaker) ? Advanced liver or kidney disease

Design outcomes

Primary

MeasureTime frame
Incidence of PONV in the 1st postoperative 24 hours (who will receive the rescue antiemetic when the PONV grade reaches = 2 or the 10_points likert score reaches = 4)

Secondary

MeasureTime frame
? Nausea and vomiting score will be recorded during the time periods 0 to 1, 1 to 6, 6 to 12, 12 to 24 hours postoperatively. ? 10-point Likert scale will be recorded during the time periods 0 to 1, 1 to 6, 6 to 12, 12 to 24 hours postoperatively. ? Time to 1st call for rescue analgesic. ? Post operative Visual analogue scale (VAS): 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively. ? Total dose of intraoperative fentanyle. ? Total dose of postoperative morphine in 24 hours. ? Total dose and boluses of the escape antiemetic ? Incidence of occurrence of drug induced complications: ? Metoclopramide: extrapyramidal symptoms, dyskinesia, dystonia, convulsion, hypertonia and tremor, cardiac arrhythmia. ? Ondansetron: headache, fatigue, dry mouth, malaise, and constipation. ? Cyclizine: impairment of motor function, confusion, dizziness, blurred vision, dry mouth and throat, palpitations, tachycardia, abdominal distress, constipation and headache. ? patient satisfaction: the patients completed a simple questionnaire (0, very satisfied; 1, satisfied; 2, not satisfied). ? The sedation scores (Observer’s Assessment of Alertness/ Sedation scale) (where 1 =awake / alert, 2=light sedation, 3=moderate sedation, 4=deep sedation and 5 = deep sleep) will be recorded during the time periods 0 to 1, 1 to 6, 6 to 12, 12 to 24 hours postoperatively. ? Mean arterial Blood pressure (MAP), heart rate: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively.

Countries

Egypt

Contacts

Public ContactIsmail Hammad

MD

Ismailhamad87@yahoo.com00201008105353

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026