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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fu Zhou Wang, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00815022
First received: December 26, 2008
Last updated: January 11, 2014
Last verified: January 2014
  Purpose

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 Intervention
Cesarean Delivery
Drug: bupivacaine/fentanyl/morphine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia for Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Maximum cephalad sensory blockade to pinprick, cold and touch [ Time Frame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Velocity of the sensory blockade at identical body position [ Time Frame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia ] [ Designated as safety issue: Yes ]
  • The total dose of phenylephrine required to maintain baseline arterial blood pressure [ Time Frame: From the delivery of anesthetic mixture to 25 min after spinal anesthesia ] [ Designated as safety issue: Yes ]
  • Time interval of the occurrence of the hypotension [ Time Frame: From the delivery of the anesthetic mixture to 25 min after spinal anesthesia ] [ Designated as safety issue: Yes ]

Enrollment: 400
Study Start Date: December 2008
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00815022

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: Fu Zhou Wang, Dr, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00815022     History of Changes
Other Study ID Numbers: NMU-200812-MZ32, NJFY0812009
Study First Received: December 26, 2008
Last Updated: January 11, 2014
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Temperature
Spinal anesthesia
Cesarean section
Cephalad sensory blockade
Regional anesthesia

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Fentanyl
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on October 01, 2014