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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cesarean Delivery | Drug: bupivacaine/fentanyl/morphine | Not Applicable |
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 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | December 2012 |
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
|
- Maximum cephalad sensory blockade to pinprick, cold and touch [ Time Frame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia ]
- Velocity of the sensory blockade at identical body position [ Time Frame: 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 [ Time Frame: From the delivery of anesthetic mixture to 25 min after spinal anesthesia ]
- Time interval of the occurrence of the hypotension [ Time Frame: From the delivery of the anesthetic mixture to 25 min after spinal anesthesia ]

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Ages Eligible for Study: | 19 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Nulliparous women
- > 18 years and < 45 years
Exclusion Criteria:
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- Participants younger than 18 years or older than 45 years
- Those who were not willing to or could not finish the whole study at any time
- Alcohol addictive or narcotic dependent patients
- Subjects with a nonvertex presentation
- Diagnosed diabetes mellitus and pregnancy-induced hypertension
- Twin gestation and breech presentation
- Pregnant fever

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
China, Jiangsu | |
Nanjing Maternal and Child Health Care Hospital | |
Nanjing, Jiangsu, China, 210004 |
Study Director: | XiaoFeng Shen, MD | Nanjing Medical University |
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 |