Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-01-04 @ 12:34 PM
Study NCT ID:
NCT05529004
Status:
UNKNOWN
Last Update Posted:
2022-09-06
First Post:
2022-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy
Sponsor:
Al Safwa University College
Organization:
Study Overview
Official Title:
Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: