Spinal Or General Anesthesia For Umblical Hernia Surgery

NCT06426225 | Completed

• 1 other identifier: 1646
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Umbilical Hernia; Spinal Aneshtesia; General Anesthesia

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Postoperative NRS

  Postoperative 30.minute, Postoperative 12. hour

• Postoperative Aldrete Score

  Postoperative first 1 hour

Study Arms (2)

General Anesthesia

ACTIVE COMPARATOR

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

Spinal Anesthesia

ACTIVE COMPARATOR

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

Interventions

General Anesthesia OTHER

General Anesthesia Applied Group 2 Patients.

General Anesthesia

Spinal Aneshtesia OTHER

Spinal Anesthesia and Ketofol Sedation Applied Group 1 Patients.

Spinal Anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• 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

  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.

  PMID: 34306042 BACKGROUND

MeSH Terms

Conditions

Hernia, Umbilical

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 23, 2024
• Study Start: May 15, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 15, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)