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Completed

NCT Number: NCT06426225

Spinal Or General Anesthesia For Umblical Hernia Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General anesthesia

Other

General Anesthesia Applied Group 2 Patients.

Spinal Aneshtesia

Other

Spinal Anesthesia and Ketofol Sedation Applied Group 1 Patients.

Primary outcomes

  1. Heart Rate

    Time frame: 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

  2. systolic blood pressure

    Time frame: 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

  3. diastolic blood pressure

    Time frame: 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

  4. mean arterial blood pressure

    Time frame: 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

  5. hospital stay

    Time frame: From hospital admission to discharge

    Length of hospital stay was recorded.

  6. Cost

    Time frame: From hospital admission to discharge

    Bill amount during hospitalization

Secondary outcomes

  1. Postoperative NRS

    Time frame: 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

  2. Postoperative Aldrete Score

    Time frame: Postoperative first 1 hour

    Postoperative Aldrete score was evaluated.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 23, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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