General Anesthesia, Spinal Aneshtesia, Umbilical Hernia
Conditions
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.
Interventions
OTHERGeneral Anesthesia
General Anesthesia Applied Group 2 Patients.
OTHERSpinal Aneshtesia
Spinal Anesthesia and Ketofol Sedation Applied Group 1 Patients.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost | From hospital admission to discharge | Bill amount during hospitalization |
| mean arterial blood pressure | 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 |
| hospital stay | From hospital admission to discharge | Length of hospital stay was recorded. |
| Heart Rate | 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 |
| systolic blood pressure | 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 |
| diastolic blood pressure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Aldrete Score | Postoperative first 1 hour | Postoperative Aldrete score was evaluated. |
| Postoperative NRS | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed