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

NCT ID: NCT06763510

Last Updated: 2025-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-01

Study Completion Date

2015-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Local Anaesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Isobaric levobupivacaine

Chirocaine

Intervention Type DRUG

Our 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 was 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.

Hyperbaric bupivacaine

Bupivacaine

Intervention Type DRUG

Our 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. Hyperbaric bupivacaine was 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.

Interventions

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Chirocaine

Our 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 was 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.

Intervention Type DRUG

Bupivacaine

Our 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. Hyperbaric bupivacaine was 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.

Intervention Type DRUG

Other Intervention Names

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levobupivacaine

Eligibility Criteria

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Inclusion Criteria

* Term pregnant with elective cesarean section planned under spinal anesthesia
* ASA I-II
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fatih University

OTHER

Sponsor Role collaborator

Ankara Ataturk Sanatorium Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Azra Ozanbarci

specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fatih University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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26247029-514-04-01

Identifier Type: -

Identifier Source: org_study_id

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