NCT03202459

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

June 23, 2017

Last Update Submit

June 27, 2017

Conditions

Postoperative ComplicationsPostoperative Nausea and Vomiting

Keywords

AnesthesiaComplicationsNauseaVomiting

Outcome Measures

Primary Outcomes (4)

  • Postoperative Nausea or vomiting M0

    The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery

    1 hours

  • Postoperative Nausea or vomiting M12

    The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 12 hours after surgery

    12 hours

  • Postoperative Nausea or vomiting M24

    The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 24 hours after surgery

    24 hours

  • Postoperative Nausea or vomiting M48

    The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after surgery

    48 hours

Secondary Outcomes (8)

  • Patient demographic data

    Before surgery

  • Surgical Duration

    First hour after surgery

  • Duration of postoperative anesthesia stay

    First hours after surgery

  • The length of stay in hospital

    From end of surgery until hospital discharge or 30 days after surgery

  • Time to request the first medication for nausea and vomiting

    First hour after surgery

  • +3 more secondary outcomes

Study Arms (3)

Active Comparator: Group A - gabapentin

ACTIVE COMPARATOR

The patient will receive oral 600 mg gabapentin 2 h before surgery

Drug: Group A - gabapentin 600 mg

Active Comparator: Group B - pregabalin

ACTIVE COMPARATOR

The patient will receive oral pregabalin 150 mg 2 h before surgery

Drug: Group B - pregabalin

Placebo Comparator: Group C - placebo

PLACEBO COMPARATOR

The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery

Drug: Group C - placebo

Interventions

Group A - gabapentin 600 mgDRUG

The patient will receive oral 600 mg gabapentin 2 h before surgery

Active Comparator: Group A - gabapentin
Group B - pregabalinDRUG

The patient will receive oral pregabalin 150 mg 2 h before surgery

Active Comparator: Group B - pregabalin
Group C - placeboDRUG

The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery

Placebo Comparator: Group C - placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, 01221-020, Brazil

RECRUITING

Related Publications (4)

  • Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.

    PMID: 24356162RESULT

  • Pandey CK, Priye S, Ambesh SP, Singh S, Singh U, Singh PK. Prophylactic gabapentin for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. J Postgrad Med. 2006 Apr-Jun;52(2):97-100.

    PMID: 16679671RESULT

  • Grant MC, Lee H, Page AJ, Hobson D, Wick E, Wu CL. The Effect of Preoperative Gabapentin on Postoperative Nausea and Vomiting: A Meta-Analysis. Anesth Analg. 2016 Apr;122(4):976-85. doi: 10.1213/ANE.0000000000001120.

    PMID: 26991615RESULT

  • Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.

    PMID: 22156268RESULT

MeSH Terms

Conditions

Postoperative ComplicationsPostoperative Nausea and VomitingNauseaVomiting

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Central Study Contacts

Ligia Andrade da Silva Telles Mathias, Doctor

CONTACT

+ 55 11 99386-0059rtimao@uol.com.br

Thiago Grigio, Master

CONTACT

+55 11 99298-1605grigiotr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 28, 2017

Study Start

March 2, 2017

Primary Completion

September 30, 2017

Study Completion

January 31, 2018

Last Updated

June 28, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)