Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia

Not Applicable

Completed

• Conditions: Cesarean Delivery
• Interventions: Drug: bupivacaine/fentanyl/morphine

• Registration Number: NCT00815022
• Lead Sponsor: Nanjing Medical University

Brief Summary

Several factors influence the extension of anesthetic mixture during spinal anesthesia including anesthetic gravity, body position, drug volume, and drug-delivering velocity. However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is hitherto unknown. The investigators hypothesized that different temperatures of the anesthetic mixture had different velocity of extension after spinal anesthesia. In addition, previous studies suggest that parturients have relative higher sensitivity to temperature. Herein the investigators proposed that the temperature of anesthetic mixture had more extensive effect on the cephalad sensory blockade with spinal anesthesia for cesarean delivery.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-26
• Study First Submitted QC: 2008-12-26
• Study First Posted: 2008-12-29
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-11
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

1. Nulliparous women
2. > 18 years and < 45 years

Exclusion Criteria

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
2. Participants younger than 18 years or older than 45 years
3. Those who were not willing to or could not finish the whole study at any time
4. Alcohol addictive or narcotic dependent patients
5. Subjects with a nonvertex presentation
6. Diagnosed diabetes mellitus and pregnancy-induced hypertension
7. Twin gestation and breech presentation
8. Pregnant fever

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	bupivacaine/fentanyl/morphine	Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 20 degree celsius
2	bupivacaine/fentanyl/morphine	Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 10 degree celsius
3	bupivacaine/fentanyl/morphine	Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 15 degree celsius
4	bupivacaine/fentanyl/morphine	Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 25 degree celsius
5	bupivacaine/fentanyl/morphine	Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 30 degree celsius
6	bupivacaine/fentanyl/morphine	Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 35 degree celsius

Primary Outcome Measures

Name	Time	Method
Maximum cephalad sensory blockade to pinprick, cold and touch	From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia

Secondary Outcome Measures

Name	Time	Method
Velocity of the sensory blockade at identical body position	From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia
The total dose of phenylephrine required to maintain baseline arterial blood pressure	From the delivery of anesthetic mixture to 25 min after spinal anesthesia
Time interval of the occurrence of the hypotension	From the delivery of the anesthetic mixture to 25 min after spinal anesthesia

Trial Locations

Locations (1)

Nanjing Maternal and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China