Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426225
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-07
Brief Title:
Spinal Or General Anesthesia For Umblical Hernia Surgery
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Should General Anesthesia or Spinal Aneshtesia With Ketofol Sedation Be Applied in Umblical Hernia Operations
Status:
COMPLETED
Status Verified Date:
2024-08
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:
In this study the investigators compared spinal anesthesia under ketofol ketamine-propofol combination sedation with general anesthesia in terms of intraoperative and postoperative hemodynamics respiratory parameters and cost in patients undergoing umbilical hernia operation the investigator aimed to provide the most appropriate and hemodynamically stable option for the patient to decrease the complication rates and to reduce the associated costs
Detailed Description:
This study was carried out at the Ministry of Health Ankara City Hospital Operating Room after receiving ethics committee approvalPreoperative evaluation was performed before the operation in cases undergoing elective umbilical hernia surgeryComplications and side effects are explained in detailVerbal and written consents were obtained from the subjects who agreed to participate in the studyIn patients undergoing umbilical hernia surgery general anesthesia and spinal anesthesia under propofol and ketamine ketamine-propofol combination sedation were compared in terms of intraoperative and postoperative hemodynamics aldrete score pain score respiratory parameters and cost The patients who had fasted for 8 hours before the operation were taken to the operating room without premedication
In all cases a peripheral venous catheter cannulated on the dorsal part of the hand 20G Plusflon iv Cannula India Standard monitoring was applied
Group1 As premedication 003mgkg midazolam was administered For spinal anesthesia 15 mg heavy-bupivacaine sedation was provided with ketofol
ketaminepropofol mixture was prepared as 11 5mgml propofol and 5mgml ketamine
1 mgkg ketofol administered iv Group2 As premedication 003mgkg midazolam was administeredIn general anesthesia to all patients after induction 3 mgkg propofol 06 mgkg rocuronium and 1 mcgkg fentanyl Bispectral index and non-invasive blood pressure was monitored a urinary catheter was placed Anesthesia was maintained with sevoflurane and fentanyl to keep BIS values between 40-60
In all cases a peripheral venous catheter cannulated on the dorsal part of the hand 20G Plusflon iv Cannula India Standard monitoring was applied
Group1 As premedication 003mgkg midazolam was administered For spinal anesthesia 15 mg heavy-bupivacaine sedation was provided with ketofol
ketaminepropofol mixture was prepared as 11 5mgml propofol and 5mgml ketamine
1 mgkg ketofol administered iv Group2 As premedication 003mgkg midazolam was administeredIn general anesthesia to all patients after induction 3 mgkg propofol 06 mgkg rocuronium and 1 mcgkg fentanyl Bispectral index and non-invasive blood pressure was monitored a urinary catheter was placed Anesthesia was maintained with sevoflurane and fentanyl to keep BIS values between 40-60
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