A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy

September 1, 2022 updated by: Mohammed AbdulZahra Sasaa, Al Safwa University College

Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.

As long as anesthesia is administered, postoperative nausea and vomiting (PONV) will continue to be a frequent and upsetting comorbidity. Vomiting and nausea can significantly slow down recovery, raise staffing and drug expenses, and decrease patient satisfaction during perioperative procedures.

Nausea it is a conscious recognition of subconscious excitation in area of medulla closely associated with or a part of the vomiting center, or it is sensation of discomfort at upper abdomen and unease sensation with involuntary order to vomit. While vomiting It is a mean by which the upper GIT rides of its contents when any part of upper GIT becomes irritated, over distended or over excitable.

The PONV is the most feared postoperative symptoms & it may impaired dressing , surgical repairs & increased ( bleeding , pain , risk of gastric contents aspiration ) & if it is prolonged will leads to electrolytes , fluid imbalance & dehydration ; the PONV can occurs after up to 90 % of operative procedures ; The common risk factors of PONV are : young age , female gender, history of ( PONV , motion sickness ) , those not smokers , early mobilization after surgery , early drinking & eating after operations , procedures like (laparoscopic , gynecological , abdominal , ENT , squint ) , postoperative severe pain , narcotic premedication , possibly prolonged general anesthesia , gastric distention , stimulation of the pharynx , hypoxemia , hypotension , & dehydration.

The PONV can reduced by: avoidance of triggers where possible, uses of anti-emetics drugs, techniques & procedures associated with low incidence of PONV (e.g. propofol) & give intravenous fluids; with prophylaxis the incidence is usually under 30% in high risk cases, the most effective approach for prevention of PONV is the use of multiple strategies & different drugs.

The pregabalin (C8H17NO2), is a newer drug & recently introduced at 1990. as anticonvulsive medication. We evaluated the effect of oral pregabalin on postoperative nausea and vomiting in laparoscopic cholecystectomy cases.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pregabalin has been found to minimize the need for opioid as well as non-steroid anti-inflammatory medications and relieve pain with different type of surgery, along with consideration of a diverse mechanisms, preoperative oral pregabalin has been reported to have antiemetic effect postoperatively. postoperative laparoscopic cholecystectomy, are associated with nausea and Vomiting and it's a concern that dictates the need for antiemetic which gives intravenously; as the intravenous drugs with intravenous fluid is becoming more common, the use of oral pregabalin is frequently mentioned, on the other hand, the intravenous antiemetic medication has some side effect.

Aim of the study:

To evaluate the effect of oral pregabalin on postoperative nausea and vomiting in laparoscopic cholecystectomy cases.

Design: Randomized Double Blind study.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 - < 55 years.
  • Both gender (male & female).
  • Patients ASA physical status1.
  • Procedures with high risk of postoperative nausea & vomiting.
  • Elective operations under general anesthesia with laparoscopic cholecystectomy.

Exclusion Criteria:

  • Age ≥ 55 years.
  • Emergency operations,
  • Patient refusal, allergy to pregabalin.
  • Pregnant patients, patients taken preoperative anti-emetic medications.
  • Patients with cardiac respiratory endocrine diseases.
  • Total intravenous maintenance general anesthesia and thiopental as induction agent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative pregabalin to prevent postoperative nausea & vomiting in laparoscopic surgery.
participants receive pregapalin 75mg cap orally 30 min before surgery
Drug: Oral Capsule pregapalin
oral cap of pregapalin has been administration to patient before surgery to prvent PONV
Other Names:
  • general anesthesia
Device: laparoscope device
general anesthesia with complete relaxation under laparoscopic cholecystectomy
No Intervention: placebo
participants hasn't receive pregapalin capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.
Time Frame: Baseline
Analysis of pregabalin group compare with the control group in laparoscopic cholecystectomy patients. to fined effective of oral pregapaline on PONV. we assess the incidence of postoperative nausea and vomiting by the use of Koivuranta Score.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al Safwa University College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pregabalin and PONV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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