Prevention of nausea and vomiting after surgery for stomach reduction in obese individuals.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-4bxdhb
• Date of registration: 05/06/2012
• Primary sponsor: Universidade Federal de Mato Grosso - Cuiabá, MT, Brazil
• Public title: Prevention of nausea and vomiting after surgery for stomach reduction in obese individuals.
• Scientific title: Prevention of nausea and vomiting in obese patients undergoing laparoscopic bariatric surgery: A comparison between three schemes. - PONV: Postoperative nausea and vomiting
• Date of first enrolment: 01/01/2011
• Target sample size: 96
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-4bxdhb/
• Study design: Preventive, parallel, three-arms, randomized, double-blind, phase 4 clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Márcio Benevides
• Affiliation: Universidade Federal de Mato Grosso

• Name: Márcio Benevides
• Affiliation: Universidade Federal de Mato Grosso

Key inclusion & exclusion criteria

Inclusion criteria: Patients aged between 18 and 65 years;
Obese patients with body mass index (BMI) greater than or equal 35 kg/m2;
Classified as physical status I-III of the American Society of Anesthesiologists (ASA);
Candidates for bariatric surgery, like laparoscopic sleeve gastrectomy under balanced general anesthesia
Exclusion criteria: Hypersensitivity or contraindication to study drugs;
Serious complications in the perioperative period;
Psychiatric disorder and a history of migraine;
Used opóide, anti-inflammatory hormone and anti-emetic medication 24 hours prior to surgery

Age minimum: 18Y
Age maximum: 65Y
Gender: -

Health Condition(s) or Problem(s) studied

Nausea and vomiting postoperative Obesity
C23.550.767.859
C18.654.726.500

Intervention(s)

96 patients scheduled for laparoscopic sleeve gastrectomy were randomized to receive:
Group O(n=32): ondansetron 8 mg IV;
Group DO(n=32): ondansetron 8 mg IV and dexamethasone 8 mg IV;
Group HDO(n=32): haloperidol 2 mg IV, dexamethasone 8 mg IV and ondansetron 8 mg IV.
Dexamethasone and haloperidol were administered in the induction of anesthesia and ondasetron 20-30 minutes before surgery.

Primary Outcome(s)

Reducing the occurrence of nausea, measured by registration of occurrence of nausea (yes or no; categorical data) for the periods 0-2, 2-12, 12-24, 24-36 and 0-36 h after surgery. Reducing the intensity of nausea, measured by verbal numeric scale of nausea (VNSN) for the periods 0-2, 2-12, 12-24, 24-36 h PO. We observed the worst assessment at the end of each period. Reducing the occurrence of vomiting, by recording the occurrence of vomiting (yes or no; categorical data), as well as counting the number of episodes occurring during periods of 0-2, 2-12, 12-24, 24-36 and 0-36 h postoperatively. Increased time to first rescue antiemetic administration as measured by the time the first dose of dimenhydrinate and / or metoclopramide as rescue antiemetic for nausea and vomiting during the period of 36 h postoperatively. Reducing the number of antiemetic rescue, assessed by recording the number of times you used dimenhydrinate and / or metoclopramide as rescue antiemetic for nausea and vomiting during the period of 36 h postoperatively.

Secondary Outcome(s)

Reduction of pain intensity and morphine consumption. Pain intensity at rest was evaluated by verbal numeric pain scale (VNPS) for the periods 0-2, 2-12, 12-24, 24-36 h postoperatively. We observed the worst assessment at the end of each period. Was recorded morphine consumption in mg by the patient during the period of 36 h postoperatively. reducing the amount of fluid in the IV administered PO, assessed by registering the amount of IV fluid administered to the patient until the PO discharge. Reduction of hospital stay, evaluated by the criteria that guided the hospital: no nausea or vomiting, pain, mild, controlled by oral analgesics, good acceptance of the diet and the absence of other medical conditions that demandassem medical attention in hospital. It was recorded at the time of discharge, length of hospital stay in hours. Occurrence of few side effects, evaluated by recording the occurrence of side effects: extrapyramidal syndrome (defined as motor restlessness, acute dystonia and dyskinesia), dysphoria, headache, dizziness or vertigo and others by performing clinical examination, the researcher.

Secondary ID(s)

932/2010

Source(s) of Monetary Support

Universidade Federal de Mato Grosso - Cuiabá, MT, Brazil

Secondary Sponsor(s)

Universidade Federal de Mato Grosso - Cuiabá, MT, Brazil