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Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT03202459
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Lígia Andrade da Silva Telles mathias, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Brief Summary:
Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it becomes important the adequate control of PONV, aiming at the satisfaction of the patient with the procedure, lower costs for the health system as well as reduction of complications in the postoperative period. This study aims to evaluate the association of gabapentin or pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess side effects.

Condition or disease Intervention/treatment Phase
Postoperative Complications Postoperative Nausea and Vomiting Drug: Group A - gabapentin 600 mg Drug: Group B - pregabalin Drug: Group C - placebo Not Applicable

Detailed Description:
The study included 60 patients at high risk for PONV (Apfel-score 0, I, II, III and IV) scheduled for elective laparoscopic surgeries at the Central Surgical Center of Irmandade da Santa Casa de Misericórdia in São Paulo. Inclusion criteria will be ASA I or II of either sex, in the age range of 18 to 70 years. In this study, the recruited patients will be allocated randomly into three groups. The group A will receive oral 600 mg gabapentin 2 h before surgery. The group B will receive oral 150 mg pregabalin 2 h before surgery. The Group C will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery. This study is "double-blind", in which neither the doctor nor the patient knows what medicine is being given.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
Actual Study Start Date : March 2, 2017
Estimated Primary Completion Date : September 30, 2017
Estimated Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Comparator: Group A - gabapentin
The patient will receive oral 600 mg gabapentin 2 h before surgery
Drug: Group A - gabapentin 600 mg
The patient will receive oral 600 mg gabapentin 2 h before surgery

Active Comparator: Active Comparator: Group B - pregabalin
The patient will receive oral pregabalin 150 mg 2 h before surgery
Drug: Group B - pregabalin
The patient will receive oral pregabalin 150 mg 2 h before surgery

Placebo Comparator: Placebo Comparator: Group C - placebo
The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery
Drug: Group C - placebo
The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery




Primary Outcome Measures :
  1. Postoperative Nausea or vomiting M0 [ Time Frame: 1 hours ]
    The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery

  2. Postoperative Nausea or vomiting M12 [ Time Frame: 12 hours ]
    The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 12 hours after surgery

  3. Postoperative Nausea or vomiting M24 [ Time Frame: 24 hours ]
    The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 24 hours after surgery

  4. Postoperative Nausea or vomiting M48 [ Time Frame: 48 hours ]
    The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after surgery


Secondary Outcome Measures :
  1. Patient demographic data [ Time Frame: Before surgery ]
    With a questionnaire will be studied the variables: age, sex, weight, height, BMI

  2. Surgical Duration [ Time Frame: First hour after surgery ]
    Time of surgery

  3. Duration of postoperative anesthesia stay [ Time Frame: First hours after surgery ]
    Time to postoperative anesthesia care unit discharge alive (hours)

  4. The length of stay in hospital [ Time Frame: From end of surgery until hospital discharge or 30 days after surgery ]
    Time of stay in hospital

  5. Time to request the first medication for nausea and vomiting [ Time Frame: First hour after surgery ]
    Reported by the patient or by a healthcare provider

  6. Amount of medication [ Time Frame: During the first 30 days after surgery ]
    Reported by a healthcare provider

  7. Postoperative complications [ Time Frame: During the first 30 days after surgery ]
    Postoperative complications after surgery

  8. Degree of patient satisfaction [ Time Frame: Before discharge ]
    The patient's overall satisfaction will be assessed using point scales (very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing laparoscopic procedures
  • Apfel Score 0, I, II, III and IV
  • ASA I / II

Exclusion Criteria:

  • Patients with surgery converted to open before thirty minutes of surgery
  • Patients who were exposed previously to gabapentin or pregabalin Patients who have allergy to any medicine used in the study
  • Patient who have to any cognitive impairment
  • Illiterate patients
  • Patients who refuse to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202459


Contacts
Contact: Ligia Andrade da Silva Telles Mathias, Doctor + 55 11 99386-0059 rtimao@uol.com.br
Contact: Thiago Grigio, Master +55 11 99298-1605 grigiotr@gmail.com

Locations
Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo Recruiting
São Paulo, Brazil, 01221-020
Contact: Thiago Ramos Grigio, Master    +55 11 99298-1605    grigiotr@gmail.com   
Principal Investigator: Ligia Andrade da Silva Telles Mathias, Doctor         
Sub-Investigator: Patrícia Mara Beltrame, Medical Residency         
Sub-Investigator: Rodolfo Brito Maia, Medical Residency         
Sub-Investigator: Paulo Henrique Borges Teixeira Lima, Medical Residency         
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Publications of Results:
Responsible Party: Lígia Andrade da Silva Telles mathias, Doctor, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT03202459     History of Changes
Other Study ID Numbers: 56057116.0.0000.5479
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lígia Andrade da Silva Telles mathias, Faculdade de Ciências Médicas da Santa Casa de São Paulo:
Anesthesia
Complications
Nausea
Vomiting

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Nausea
Postoperative Complications
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes
Pregabalin
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents