search
Back to results

Preemptive Versus Preventive Antiemetic Treatment

Primary Purpose

Postoperative Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Antiemetics perioperatively
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

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

Inclusion Criteria:

  • ASA physical status I-III patients
  • Surgical procedure: scheduled for laparoscopic cholecystectomy
  • Type of anesthesia: general

Exclusion Criteria:

  • Antihistamines the last three days
  • Antiemetic drugs the last three days
  • Hiatus hernia
  • reflux
  • Gastrointestinal disease
  • Pregnancy
  • BMI > 35
  • parkinson
  • known allergy to the drugs of the protocol
  • epilepsy

Sites / Locations

  • Aretaieio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

preemptive group

intraoperative group

Arm Description

The preemptive group will receive the anti-emetic regimen i.v. (4 mg of ondansetron) 1h before the start of surgery. During surgery, 30 min before the end of operation, this group will receive i.v. 0.9% NaCl in equal volumes.The intervention consists of the different time points of antiemetic treatment, thus 1h before surgery vs intraopertively. Intervention: Antiemetic treatment 1h before surgery

The preventive group will receive i.v. 0.9% NaCl 1h before surgery and ondansetron 4 mg 30 min before the end of surgery at equal volumes. Intervention: Antiemetic treatment intraoperatively

Outcomes

Primary Outcome Measures

PONV (postoperative nausea vomiting combined)
Incidence of combined nausea and vomiting postoperatively

Secondary Outcome Measures

postoperative nausea frequency and intensity
numerical rating scale of nausea intensity (0-10)
postoperative vomiting frequency
number of vomits
postoperative pain
numerical rating scale of pain intensity (0-10)
retching
if retching exists
PONV (postoperative nausea vomiting combined)
frequency and intensity of nausea and vomiting

Full Information

First Posted
January 13, 2017
Last Updated
October 31, 2018
Sponsor
University of Athens
search

1. Study Identification

Unique Protocol Identification Number
NCT03023306
Brief Title
Preemptive Versus Preventive Antiemetic Treatment
Official Title
Effectiveness of Preemptive Versus Preventive Antiemetic Treatment in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized Double Blind Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens

4. Oversight

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

5. Study Description

Brief Summary
Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study. Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before the start of surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively, 30 min before the end of surgery. In the operating room standard monitoring and a standardized anesthetic technique will be implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical rating scale) will be recorded at the same time points. Also, when patients received fluids and solid food by mouth will be recorded.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preemptive group
Arm Type
Active Comparator
Arm Description
The preemptive group will receive the anti-emetic regimen i.v. (4 mg of ondansetron) 1h before the start of surgery. During surgery, 30 min before the end of operation, this group will receive i.v. 0.9% NaCl in equal volumes.The intervention consists of the different time points of antiemetic treatment, thus 1h before surgery vs intraopertively. Intervention: Antiemetic treatment 1h before surgery
Arm Title
intraoperative group
Arm Type
Other
Arm Description
The preventive group will receive i.v. 0.9% NaCl 1h before surgery and ondansetron 4 mg 30 min before the end of surgery at equal volumes. Intervention: Antiemetic treatment intraoperatively
Intervention Type
Other
Intervention Name(s)
Antiemetics perioperatively
Intervention Description
Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively
Primary Outcome Measure Information:
Title
PONV (postoperative nausea vomiting combined)
Description
Incidence of combined nausea and vomiting postoperatively
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
postoperative nausea frequency and intensity
Description
numerical rating scale of nausea intensity (0-10)
Time Frame
24 hours
Title
postoperative vomiting frequency
Description
number of vomits
Time Frame
24 hours
Title
postoperative pain
Description
numerical rating scale of pain intensity (0-10)
Time Frame
24 hours
Title
retching
Description
if retching exists
Time Frame
24 hours
Title
PONV (postoperative nausea vomiting combined)
Description
frequency and intensity of nausea and vomiting
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I-III patients Surgical procedure: scheduled for laparoscopic cholecystectomy Type of anesthesia: general Exclusion Criteria: Antihistamines the last three days Antiemetic drugs the last three days Hiatus hernia reflux Gastrointestinal disease Pregnancy BMI > 35 parkinson known allergy to the drugs of the protocol epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Argyro Fassoulaki, MD PhD DEAA
Phone
306936701333
Email
afassou1@otenet.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Chryssoula Staikou, MD, PhD, DESA
Phone
00306932352742
Email
c_staikou@yahoo.gr
Facility Information:
Facility Name
Aretaieio University Hospital
City
Athens
State/Province
Attika
ZIP/Postal Code
11528
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Argyro Fassoulaki, MD PhD DEAA
Phone
306936701333
Email
fassoula@aretaieio.uoa.gr
First Name & Middle Initial & Last Name & Degree
Chryssoula Staikou, MD PhD DESA
Phone
00306932352742
Email
c_staikou@yahoo.gr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25370136
Citation
Odom-Forren J, Rayens MK, Gokun Y, Jalota L, Radke O, Hooper V, Wiggins AT, Apfel CC. The Relationship of Pain and Nausea in Postoperative Patients for 1 Week After Ambulatory Surgery. Clin J Pain. 2015 Oct;31(10):845-51. doi: 10.1097/AJP.0000000000000170.
Results Reference
background
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
background
PubMed Identifier
23035051
Citation
Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.
Results Reference
background
PubMed Identifier
22593126
Citation
Apfel CC, Meyer A, Orhan-Sungur M, Jalota L, Whelan RP, Jukar-Rao S. Supplemental intravenous crystalloids for the prevention of postoperative nausea and vomiting: quantitative review. Br J Anaesth. 2012 Jun;108(6):893-902. doi: 10.1093/bja/aes138.
Results Reference
background
PubMed Identifier
27270883
Citation
Wallden J, Flodin J, Hultin M. Validation of a prediction model for post-discharge nausea and vomiting after general anaesthesia in a cohort of Swedish ambulatory surgery patients. Eur J Anaesthesiol. 2016 Oct;33(10):743-9. doi: 10.1097/EJA.0000000000000473.
Results Reference
background

Learn more about this trial

Preemptive Versus Preventive Antiemetic Treatment

We'll reach out to this number within 24 hrs