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

Nanjing Medical University

Status: Completed

Conditions: Cesarean Delivery

Treatments: Drug: bupivacaine/fentanyl/morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT00815022

NMU-200812-MZ32

NJFY0812009

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 6 patient groups

1

Active Comparator group

Description:

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 20 degree celsius

Treatment:

Drug: bupivacaine/fentanyl/morphine

2

Experimental group

Description:

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 10 degree celsius

Treatment:

Drug: bupivacaine/fentanyl/morphine

3

Experimental group

Description:

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 15 degree celsius

Treatment:

Drug: bupivacaine/fentanyl/morphine

4

Experimental group

Description:

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 25 degree celsius

Treatment:

Drug: bupivacaine/fentanyl/morphine

5

Experimental group

Description:

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 30 degree celsius

Treatment:

Drug: bupivacaine/fentanyl/morphine

6

Experimental group

Description:

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 35 degree celsius

Treatment:

Drug: bupivacaine/fentanyl/morphine