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Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

Primary Purpose

Postoperative Complications, Postoperative Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Group A - gabapentin 600 mg
Group B - pregabalin
Group C - placebo
Sponsored by
Faculdade de Ciências Médicas da Santa Casa de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Complications focused on measuring Anesthesia, Complications, Nausea, Vomiting

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Irmandade da Santa Casa de Misericórdia de São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Active Comparator: Group A - gabapentin

Active Comparator: Group B - pregabalin

Placebo Comparator: Group C - placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Postoperative Nausea or vomiting M0
The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery
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
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
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

Secondary Outcome Measures

Patient demographic data
With a questionnaire will be studied the variables: age, sex, weight, height, BMI
Surgical Duration
Time of surgery
Duration of postoperative anesthesia stay
Time to postoperative anesthesia care unit discharge alive (hours)
The length of stay in hospital
Time of stay in hospital
Time to request the first medication for nausea and vomiting
Reported by the patient or by a healthcare provider
Amount of medication
Reported by a healthcare provider
Postoperative complications
Postoperative complications after surgery
Degree of patient satisfaction
The patient's overall satisfaction will be assessed using point scales (very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)

Full Information

First Posted
June 23, 2017
Last Updated
June 27, 2017
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03202459
Brief Title
Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
Official Title
Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Anticipated)
Study Completion Date
January 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Postoperative Nausea and Vomiting
Keywords
Anesthesia, Complications, Nausea, Vomiting

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: Group A - gabapentin
Arm Type
Active Comparator
Arm Description
The patient will receive oral 600 mg gabapentin 2 h before surgery
Arm Title
Active Comparator: Group B - pregabalin
Arm Type
Active Comparator
Arm Description
The patient will receive oral pregabalin 150 mg 2 h before surgery
Arm Title
Placebo Comparator: Group C - placebo
Arm Type
Placebo Comparator
Arm Description
The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery
Intervention Type
Drug
Intervention Name(s)
Group A - gabapentin 600 mg
Intervention Description
The patient will receive oral 600 mg gabapentin 2 h before surgery
Intervention Type
Drug
Intervention Name(s)
Group B - pregabalin
Intervention Description
The patient will receive oral pregabalin 150 mg 2 h before surgery
Intervention Type
Drug
Intervention Name(s)
Group C - placebo
Intervention Description
The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery
Primary Outcome Measure Information:
Title
Postoperative Nausea or vomiting M0
Description
The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery
Time Frame
1 hours
Title
Postoperative Nausea or vomiting M12
Description
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 12 hours after surgery
Time Frame
12 hours
Title
Postoperative Nausea or vomiting M24
Description
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 24 hours after surgery
Time Frame
24 hours
Title
Postoperative Nausea or vomiting M48
Description
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after surgery
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Patient demographic data
Description
With a questionnaire will be studied the variables: age, sex, weight, height, BMI
Time Frame
Before surgery
Title
Surgical Duration
Description
Time of surgery
Time Frame
First hour after surgery
Title
Duration of postoperative anesthesia stay
Description
Time to postoperative anesthesia care unit discharge alive (hours)
Time Frame
First hours after surgery
Title
The length of stay in hospital
Description
Time of stay in hospital
Time Frame
From end of surgery until hospital discharge or 30 days after surgery
Title
Time to request the first medication for nausea and vomiting
Description
Reported by the patient or by a healthcare provider
Time Frame
First hour after surgery
Title
Amount of medication
Description
Reported by a healthcare provider
Time Frame
During the first 30 days after surgery
Title
Postoperative complications
Description
Postoperative complications after surgery
Time Frame
During the first 30 days after surgery
Title
Degree of patient satisfaction
Description
The patient's overall satisfaction will be assessed using point scales (very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)
Time Frame
Before discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ligia Andrade da Silva Telles Mathias, Doctor
Phone
+ 55 11 99386-0059
Email
rtimao@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Thiago Grigio, Master
Phone
+55 11 99298-1605
Email
grigiotr@gmail.com
Facility Information:
Facility Name
Irmandade da Santa Casa de Misericórdia de São Paulo
City
São Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiago Ramos Grigio, Master
Phone
+55 11 99298-1605
Email
grigiotr@gmail.com
First Name & Middle Initial & Last Name & Degree
Ligia Andrade da Silva Telles Mathias, Doctor
First Name & Middle Initial & Last Name & Degree
Patrícia Mara Beltrame, Medical Residency
First Name & Middle Initial & Last Name & Degree
Rodolfo Brito Maia, Medical Residency
First Name & Middle Initial & Last Name & Degree
Paulo Henrique Borges Teixeira Lima, Medical Residency

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24356162
Citation
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. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494.
Results Reference
result
PubMed Identifier
16679671
Citation
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.
Results Reference
result
PubMed Identifier
26991615
Citation
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.
Results Reference
result
PubMed Identifier
22156268
Citation
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.
Results Reference
result

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Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

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