MedTrace Logo

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

NCT05529004 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-09-06

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

Oral Capsule pregapalin

oral cap of pregapalin has been administration to patient before surgery to prvent PONV

DEVICE

laparoscope device

general anesthesia with complete relaxation under laparoscopic cholecystectomy

Sponsors & Collaborators

  • Al Safwa University College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2022-10-01
Completion
2023-04-30
FDA Drug
Yes
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05529004 on ClinicalTrials.gov