Spinal Or General Anesthesia For Umblical Hernia Surgery

Should General Anesthesia or Spinal Aneshtesia With Ketofol Sedation Be Applied in Umblical Hernia Operations ?

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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia; Umbilical Hernia; Spinal Aneshtesia
• Intervention / Treatment: Other: General Anesthesia; Other: Spinal Aneshtesia

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: General Anesthesia; General Anesthesia Applied Group 2 Patients.
Active Comparator: Spinal Anesthesia; 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.	Other: Spinal Aneshtesia; Spinal Anesthesia and Ketofol Sedation Applied Group 1 Patients.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• KROBOT, R. i PREMUŽIĆ, J. (2013). Comparison of general and spinal anaesthesia in patients undergoing open ventral hernia repair. Periodicum biologorum, 115 (2), 225-229. Preuzeto s https://hrcak.srce.hr/105984
• Germano P, Siboni S, Milito P, Mautone G, Resta M, Bonavina L. Ventral hernia repair under neuraxial anesthesia. Eur Surg. 2022;54(1):54-58. doi: 10.1007/s10353-021-00731-x. Epub 2021 Jul 20.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia, Ventral; Hernia; Hernia, Umbilical; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 1646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No