Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288035
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-24
Brief Title:
Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Oral Dexamethasone at Night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy A Protocol for Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
Postoperative nausea and vomiting PONV are common complications after laparoscopic cholecystectomy This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy
Detailed Description:
Background
Postoperative nausea and vomiting PONV are common complications after laparoscopic cholecystectomy This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy as it reaches its peak effect at 2-12 hours and lasts for 72 hours after oral administration
Methods
This is a parallel two-arm randomized 11 controlled single-center non-inferiority trial Adults 18 years with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone 12 hours before induction of anesthesia The primary outcome will be the incidence of postoperative nausea and vomiting A total of 814 patients are intended to be recruited for this non-inferiority trial
Discussion
The current randomized trial is exploring the non-inferiority and feasibility of oral dexamethasone at night to reduce the PONV after laparoscopic cholecystectomy when compared to the standard of care - intravenous dexamethasone at the time of induction Additionally the investigators suppose oral dexamethasone at night is easier to administer avoids polypharmacy at the time of induction of anesthesia avoids the unpleasant sensation of intravenous injection and is at a lower cost for a one-day surgery
Postoperative nausea and vomiting PONV are common complications after laparoscopic cholecystectomy This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy as it reaches its peak effect at 2-12 hours and lasts for 72 hours after oral administration
Methods
This is a parallel two-arm randomized 11 controlled single-center non-inferiority trial Adults 18 years with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone 12 hours before induction of anesthesia The primary outcome will be the incidence of postoperative nausea and vomiting A total of 814 patients are intended to be recruited for this non-inferiority trial
Discussion
The current randomized trial is exploring the non-inferiority and feasibility of oral dexamethasone at night to reduce the PONV after laparoscopic cholecystectomy when compared to the standard of care - intravenous dexamethasone at the time of induction Additionally the investigators suppose oral dexamethasone at night is easier to administer avoids polypharmacy at the time of induction of anesthesia avoids the unpleasant sensation of intravenous injection and is at a lower cost for a one-day surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None