ATOCEB: Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia

Sponsor

Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT00815022

Collaborator

(none)

400

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Delivery	Drug: bupivacaine/fentanyl/morphine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia for Cesarean Delivery

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 20 degree celsius	Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
Experimental: 2 Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 10 degree celsius	Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
Experimental: 3 Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 15 degree celsius	Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
Experimental: 4 Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 25 degree celsius	Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
Experimental: 5 Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 30 degree celsius	Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
Experimental: 6 Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 35 degree celsius	Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Nulliparous women
18 years and < 45 years

Exclusion Criteria:

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