Spinal Or General Anesthesia For Umblical Hernia Surgery

Not Applicable

Completed

• Conditions: Umbilical Hernia; Spinal Aneshtesia; General Anesthesia
• Interventions: Other: Spinal Aneshtesia; Other: General Anesthesia

• Registration Number: NCT06426225
• Lead Sponsor: Ankara City Hospital Bilkent

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 approval.Preoperative evaluation was performed before the operation in cases undergoing elective umbilical hernia surgery.Complications and side effects are explained in detail.Verbal and written consents were obtained from the subjects who agreed to participate in the study.In 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 i.v. Cannula, India) .Standard monitoring was applied.

Group1. As premedication 0.03mg/kg midazolam was administered . For spinal anesthesia, 15 mg heavy-bupivacaine, sedation was provided with ketofol.

ketamine:propofol mixture was prepared as 1:1 5mg/ml propofol and 5mg/ml ketamine

1 mg/kg ketofol administered i.v. Group2 . As premedication 0.03mg/kg midazolam was administered.In general anesthesia to all patients after induction 3 mg/kg propofol, 0.6 mg/kg rocuronium and 1 mcg/kg 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 Timeline

• Study First Submitted: 2024-05-07
• Study Start: 2024-05-15
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-23
• Status Verified: 2024-08
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-15
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• ASA I-II patients between the ages of 18 and 65 who would undergo Umbilical hernia surgery were included in the study.

Exclusion Criteria

• who do not accept the procedure
• serious cardiovasculer disease ,renal, hematological (bleeding diathesis, under anticoagulant therapy, those with hemoglobin value below 10 g/dl) disease, hepatic disease, cerebrovascular, neurological or psychiatric diseases,
• those who are contraindicated for spinal anesthesia,
• Those who are allergic to one of the local anesthetics to be used, with drug and alcohol addiction,
• pregnant or breastfeeding
• using drugs and analgesics effective on the central nervous system were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal Anesthesia	Spinal Aneshtesia	As premedication 0.03mg/kg midazolam was administered. After premedication Spinal Anesthesia applied. Group will be sedated with ketofol after spinal anesthesia. Ketamine:propofol mixture will be prepared as 1:1 5mg/ml propofol and 5mg/ml ketamine. Surgery will begin when the Ramsey sedation scale reaches 3.
General Anesthesia	General Anesthesia	As premedication 0.03mg/kg midazolam was administered. During general anesthesia, 3 mg/kg propofol, 0.6 mg/kg rocuronium and 1 mcg/kg fentanyl were administered to all patients for induction.

Primary Outcome Measures

Name	Time	Method
Heart Rate	preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute	During Perioperative Period Heart rate was measured
systolic blood pressure	preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute	non invasive blood pressure measurement
diastolic blood pressure	preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute	non invasive blood pressure measurement
Cost	From hospital admission to discharge	Bill amount during hospitalization
hospital stay	From hospital admission to discharge	Length of hospital stay was recorded.
mean arterial blood pressure	preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute	non invasive blood pressure measurement

Secondary Outcome Measures

Name	Time	Method
Postoperative Aldrete Score	Postoperative first 1 hour	Postoperative Aldrete score was evaluated.
Postoperative NRS	Postoperative 30.minute, Postoperative 12. hour	postoperative numeric rating scale was evaluated, 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey