Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia (ATOCEB)
This study has been completed.
Sponsor:
Nanjing Medical University
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
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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:
MedlinePlus related topics:
Cesarean Section
Drug Information available for:
Morphine sulfate
Fentanyl
Fentanyl citrate
Bupivacaine hydrochloride
Bupivacaine
U.S. FDA Resources
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 (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00815022
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
| 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 Anesthetics, Local Sensory System Agents |
Peripheral Nervous System Agents Analgesics, Opioid Narcotics Analgesics Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General |
ClinicalTrials.gov processed this record on September 27, 2016