Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia

Cesarean Delivery Clinical Trial

— ATOCEB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815022
• Other study ID #: NMU-200812-MZ32
• Secondary ID: NJFY0812009
• Status: Completed
• Phase: N/A
• First received: December 26, 2008
• Last updated: January 11, 2014
• Start date: December 2008
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Delivery

Intervention

Drug:
• bupivacaine/fentanyl/morphine
Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum cephalad sensory blockade to pinprick, cold and touch		From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia	Yes
Secondary	Velocity of the sensory blockade at identical body position		From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia	Yes
Secondary	The total dose of phenylephrine required to maintain baseline arterial blood pressure		From the delivery of anesthetic mixture to 25 min after spinal anesthesia	Yes
Secondary	Time interval of the occurrence of the hypotension		From the delivery of the anesthetic mixture to 25 min after spinal anesthesia	Yes