Spinal Or General Anesthesia For Umblical Hernia Surgery

NCT ID: NCT06426225

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2024-08-15

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.

Conditions

Umbilical Hernia; Spinal Aneshtesia; General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

General Anesthesia

Intervention Type: OTHER

General Anesthesia Applied Group 2 Patients.

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.

Group Type: ACTIVE_COMPARATOR

Spinal Aneshtesia

Intervention Type: OTHER

Spinal Anesthesia and Ketofol Sedation Applied Group 1 Patients.

Interventions

General Anesthesia

General Anesthesia Applied Group 2 Patients.

Intervention Type: OTHER

Spinal Aneshtesia

Spinal Anesthesia and Ketofol Sedation Applied Group 1 Patients.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Nargiz Mammadova

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 34306042 (View on PubMed)

Other Identifiers

1646

Identifier Type: -

Identifier Source: org_study_id