Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288542
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-25
Brief Title:
Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
The Relationship of Preoperative Intravenous Dextrose Infusion to Postoperative Nausea and Vomiting in Gynecological Laparoscopic and Hysteroscopic Surgeries A Randomized Control Trial
Status:
NOT_YET_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:
This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5 during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures
Detailed Description:
A history of PONV risk factors will be recorded After consenting patients will be assigned using a computerized randomization function to Ringer solution group R or 5 dextrose group D or control group group C Group D will receive 1 mLkgh 5 Dextrose infusion applied preoperatively during fasting until induction of anesthesia Group R will receive 1 mLkgh ringer infusion applied preoperatively during fasting until induction of anesthesia Group C will receive no fluids The anesthesia providers surgeons perioperative nurses postanesthesia care unit PACU nurses and investigators will be blinded to group assignment throughout
As for pre-medication all patients will receive IV midazolam 002 mgkg Anesthesia will be induced with propofol 15-2 mgkg fentanyl 1-2 μgkg and atracuriumo5mgkg to facilitate endotracheal intubation The lungs will be mechanically ventilated and anesthesia will be maintained with isoflurane in O2air Intraoperative IV maintenance fluid will be standardized at 3 mLkgh with additional IV crystalloid given as needed at the discretion of the anesthesia provider if arterial blood pressure decreased gt20 from baseline For postoperative pain relief paracetamol 1 g will be given IV during surgery in all patients and continued orally after operation 1g every 6 h In addition all patients will be ambulated within 6 h after completion of surgery Standardized antiemetic and analgesic rescue medications will be available Patients will receive no rescue antiemetic medication when the VRS score is 0 to 2 1 dose of rescue medication when the VRS score is 3 to 6 and 2 doses for nausea score of 7 to 10 to reduce the nausea score to 0 to 2
As for pre-medication all patients will receive IV midazolam 002 mgkg Anesthesia will be induced with propofol 15-2 mgkg fentanyl 1-2 μgkg and atracuriumo5mgkg to facilitate endotracheal intubation The lungs will be mechanically ventilated and anesthesia will be maintained with isoflurane in O2air Intraoperative IV maintenance fluid will be standardized at 3 mLkgh with additional IV crystalloid given as needed at the discretion of the anesthesia provider if arterial blood pressure decreased gt20 from baseline For postoperative pain relief paracetamol 1 g will be given IV during surgery in all patients and continued orally after operation 1g every 6 h In addition all patients will be ambulated within 6 h after completion of surgery Standardized antiemetic and analgesic rescue medications will be available Patients will receive no rescue antiemetic medication when the VRS score is 0 to 2 1 dose of rescue medication when the VRS score is 3 to 6 and 2 doses for nausea score of 7 to 10 to reduce the nausea score to 0 to 2
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