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

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Delivery
• Intervention / Treatment: Drug: bupivacaine/fentanyl/morphine

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: December 26, 2008
• First Submitted That Met QC Criteria: December 26, 2008
• First Posted (ESTIMATE): December 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 11, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Cesarean section; Spinal anesthesia; Temperature; Regional anesthesia; Cephalad sensory blockade
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine; Morphine
• Other Study ID Numbers: NMU-200812-MZ32; NJFY0812009