A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy
Primary Purpose
Postoperative Nausea and Vomiting
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Oral Capsule pregapalin
laparoscope device
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring nausea, vomiting, cholecystectomy, oral pregapalin
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Preoperative pregabalin to prevent postoperative nausea & vomiting in laparoscopic surgery.
placebo
Arm Description
participants receive pregapalin 75mg cap orally 30 min before surgery
participants hasn't receive pregapalin capsule
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05529004
First Posted
August 30, 2022
Last Updated
September 1, 2022
Sponsor
Al Safwa University College
1. Study Identification
Unique Protocol Identification Number
NCT05529004
Brief Title
A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy
Official Title
Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al Safwa University College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
nausea, vomiting, cholecystectomy, oral pregapalin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized Double Blind study.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative pregabalin to prevent postoperative nausea & vomiting in laparoscopic surgery.
Arm Type
Experimental
Arm Description
participants receive pregapalin 75mg cap orally 30 min before surgery
Arm Title
placebo
Arm Type
No Intervention
Arm Description
participants hasn't receive pregapalin capsule
Intervention Type
Drug
Intervention Name(s)
Oral Capsule pregapalin
Other Intervention Name(s)
general anesthesia
Intervention Description
oral cap of pregapalin has been administration to patient before surgery to prvent PONV
Intervention Type
Device
Intervention Name(s)
laparoscope device
Intervention Description
general anesthesia with complete relaxation under laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Preoperative Pregabalin to Prevent Postoperative Nausea & Vomiting in Laparoscopic Surgery.
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed abdulzahra sasaa, phd
Phone
009647718991533
Ext
AZ
Email
m.abedalzahraa@alsafwa.edu.iq
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed AN sahib, phd
Phone
009647815759208
Email
smralmmwry@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15064261
Citation
Habib AS, Gan TJ. Evidence-based management of postoperative nausea and vomiting: a review. Can J Anaesth. 2004 Apr;51(4):326-41. doi: 10.1007/BF03018236.
Results Reference
background
PubMed Identifier
8669567
Citation
Koivuranta MK, Laara E, Ryhanen PT. Antiemetic efficacy of prophylactic ondansetron in laparoscopic cholecystectomy. A randomised, double-blind, placebo-controlled trial. Anaesthesia. 1996 Jan;51(1):52-55. doi: 10.1111/j.1365-2044.1996.tb07654.x.
Results Reference
background
PubMed Identifier
32467512
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. Erratum In: Anesth Analg. 2020 Nov;131(5):e241.
Results Reference
background
PubMed Identifier
16846542
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. doi: 10.1185/030079906X104830.
Results Reference
result
PubMed Identifier
7986507
Citation
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. doi: 10.1016/s0952-8180(05)80004-2.
Results Reference
result
PubMed Identifier
17885699
Citation
Metz A, Hebbard G. Nausea and vomiting in adults--a diagnostic approach. Aust Fam Physician. 2007 Sep;36(9):688-92.
Results Reference
result
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A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy
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