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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05529004
• Other study ID #: pregabalin and PONV
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2022
• Est. completion date: April 2023

Study information

• Verified date: September 2022
• Source: Al Safwa University College
• Contact: Mohammed abdulzahra sasaa, phd
• Phone: 009647718991533
• Email: m.abedalzahraa[@]alsafwa.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al Safwa University College

References & Publications (6)

Carroll NV, Miederhoff PA, Cox FM, Hirsch JD. Costs incurred by outpatient surgical centers in managing postoperative nausea and vomiting. J Clin Anesth. 1994 Sep-Oct;6(5):364-9. — View Citation

Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833. Review. Erratum in: Anesth Analg. 2020 Nov;131(5):e241. — View Citation

Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis. Curr Med Res Opin. 2006 Jun;22(6):1093-9. — View Citation

Habib AS, Gan TJ. Evidence-based management of postoperative nausea and vomiting: a review. Can J Anaesth. 2004 Apr;51(4):326-41. Review. — View Citation

Koivuranta MK, Läärä E, Ryhänen PT. Antiemetic efficacy of prophylactic ondansetron in laparoscopic cholecystectomy. A randomised, double-blind, placebo-controlled trial. Anaesthesia. 1996 Jan;51(1):52-55. — View Citation

Metz A, Hebbard G. Nausea and vomiting in adults--a diagnostic approach. Aust Fam Physician. 2007 Sep;36(9):688-92. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.	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