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Clinical Trials/NCT06763510
NCT06763510
Completed
Not Applicable

Comparison of the Effects of Two Different Local Anesthetics Used in Spinal Anesthesia

Ankara Ataturk Sanatorium Training and Research Hospital1 site in 1 country40 target enrollmentFebruary 1, 2015

Overview

Phase
Not Applicable
Intervention
Chirocaine
Conditions
Local Anaesthesia
Sponsor
Ankara Ataturk Sanatorium Training and Research Hospital
Enrollment
40
Locations
1
Primary Endpoint
Temperature
Status
Completed
Last Updated
last year

Overview

Brief Summary

Objective: This study aimed to compare the effects of two different local anesthetics with different baricity used in spinal anesthesia on thermoregulation.

Materials and Methods: The study was conducted on forty full-term pregnant women scheduled for elective cesarean sections under spinal anesthesia. At an operating room temperature of twenty-four degrees Celsius, peripheral body temperature was measured using temperature probes attached to the lower medial parts of the same side's lower and upper extremities, and central body temperature was measured with a tympanic thermometer. Isobaric levobupivacaine and hyperbaric bupivacaine were used in spinal anesthesia applications. After spinal anesthesia, tympanic temperature, arm and leg temperatures, mean arterial pressure, heart rate, and oxygen saturation were measured and recorded at baseline, the first, third, and fifth minutes, and every five minutes thereafter until the end of surgery.

Registry
clinicaltrials.gov
Start Date
February 1, 2015
End Date
July 30, 2015
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Ankara Ataturk Sanatorium Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Azra Ozanbarci

specialist

Ankara Ataturk Sanatorium Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Term pregnant with elective cesarean section planned under spinal anesthesia
  • 18-40 years old

Exclusion Criteria

  • patients in whom spinal anesthesia is contraindicated,
  • patients with neuromuscular disease,
  • alcohol and substance abusers,
  • patients with a body mass index (BMI) \<18.5 kg/m² or \>35 kg/m²,
  • those taking medications that may affect thermoregulation such as vasodilators,
  • patients with thyroid disease,
  • patients with fever and infection,
  • patients with known allergies to study drugs.

Arms & Interventions

Isobaric levobupivacaine

Intervention: Chirocaine

Hyperbaric bupivacaine

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Temperature

Time Frame: During operation

Isobaric levobupivacaine or hyperbaric bupivacaine were used in spinal anesthesia applications. After spinal anesthesia, tympanic temperature, arm and leg temperatures were measured and recorded at the beginning, first, third and fifth minutes and then every five minutes until the end of the surgery.

Study Sites (1)

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