The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

TC Erciyes University

Status and phase: Completed; Phase 4

Conditions: Perioperative/Postoperative Complications

Treatments: Drug: Levobupivacaine; Drug: Dexmedetomidine; Drug: sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01921361

B.30.2.ERC.0.01.00.01/27

Details and patient eligibility

About

The purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery.

Full description

The design of the study includes three study groups done in random order. The groups are as follows: 1) Control group received 15 mg levobupivacaine intrathecally and intravenous 0.9% sodium chloride; 2) Intravenous group received 15 mg levobupivacaine intrathecally and intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) Intrathecal group received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9% sodium chloride.

Throughout the study period,shivering scores, tympanic temperature were recorded, heart rate were measured continuously using an electrocardiogram; blood pressure was determined oscillometrically at 5 min intervals at the ankle. In case heart rate decreased by more than 30% of the baseline atropin received and blood pressure decreased 30% of the baseline effedrin received.

Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded peroperatively in the operating room and postanesthetic care unit.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-65 y/o patients
• American Society of Anesthesiologists' physical status class I-II
• Scheduled for the spinal anesthesia

Exclusion criteria

• Patients who have the body temperature over 37.3 celsius degree
• Pregnants
• Known allergies to the study drugs
• Contraindication to spinal anesthesia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Intravenous

Active Comparator group

Description:

Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous dexmedetomidine (dexmedetomidine diluted 1mcg/ml and than 1ml/kg/10 minutes and 0.5 ml/kg/hour infusion)

Treatment:

Drug: sodium chloride

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Levobupivacaine

Intrathecal

Active Comparator group

Description:

Intrathecal (3 ml) 15 mg levobupivacaine + (0.3 ml) 3 mcg dexmedetomidine (dexmedetomidine diluted 10 mcg/ml) and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion)

Treatment:

Drug: sodium chloride

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Levobupivacaine

Control

Placebo Comparator group

Description:

Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion).

Treatment:

Drug: sodium chloride

Drug: Levobupivacaine