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

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ClinicalTrials.gov Identifier: NCT00815022
Recruitment Status : Completed
First Posted : December 29, 2008
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):

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
Cesarean Delivery Drug: bupivacaine/fentanyl/morphine

Study Design

Study Type : Interventional  (Clinical Trial)
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 : December 2008
Primary Completion Date : November 2012
Study Completion Date : December 2012

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U.S. FDA Resources

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 :
  1. Maximum cephalad sensory blockade to pinprick, cold and touch [ Time Frame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia ]

Secondary Outcome Measures :
  1. Velocity of the sensory blockade at identical body position [ Time Frame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia ]
  2. 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 ]
  3. Time interval of the occurrence of the hypotension [ Time Frame: From the delivery of the anesthetic mixture to 25 min after spinal anesthesia ]

Eligibility Criteria

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes 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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fu Zhou Wang, Dr, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00815022     History of Changes
Other Study ID Numbers: NMU-200812-MZ32
NJFY0812009
First Posted: December 29, 2008    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

Keywords provided by Fu Zhou Wang, 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
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General