Spinal Or General Anesthesia For Umblical Hernia Surgery

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06426225
• Other study ID #: 1646
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: May 2024
• Source: Ankara City Hospital Bilkent
• Contact: Nargiz Mammadova
• Phone: +905356570987
• Email: nargiz188855[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 15, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthesia
• Hernia
• Hernia, Umbilical
• Umbilical Hernia

Intervention

Other:
• General Anesthesia
General Anesthesia Applied Group 2 Patients.
• Spinal Aneshtesia
Spinal Anesthesia and Ketofol Sedation Applied Group 1 Patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

References & Publications (2)

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. — View Citation

KROBOT, R. i PREMUŽIC, 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	hospital stay	Length of hospital stay was recorded.	From hospital admission to discharge
Primary	Cost	Bill amount during hospitalization	From hospital admission to discharge
Secondary	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
Secondary	Postoperative Aldrete Score	Postoperative Aldrete score was evaluated.	Postoperative first 1 hour