Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia - Full Text View

Sponsored by:	Nanjing Medical University
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00815022

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 purposed 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 Cephalad Sensory Blockade	Other: Temperature Drug: bupivacaine/fentanyl/morphine

MedlinePlus related topics: Anesthesia Cesarean Section

Drug Information available for: Fentanyl Citrate Fentanyl Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia for Cesarean Delivery

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 25min 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 25min after spinal anesthesia ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 20 degree celsius	Other: Temperature Mixture of anesthetic with the temperature of 20 degree celsius Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
2: Experimental Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 10 degree celsius	Other: Temperature Mixture of anesthetic with the temperature of 10 degree celsius Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
3: Experimental Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 15 degree celsius	Other: Temperature Mixture of anesthetic with the temperature of 15 degree celsius Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
4: Experimental Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 25 degree celsius	Other: Temperature Mixture of anesthetic with the temperature of 25 degree celsius Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
5: Experimental Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 30 degree celsius	Other: Temperature Mixture of anesthetic with the temperature of 30 degree celsius Drug: bupivacaine/fentanyl/morphine Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
6: Experimental Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 35 degree celsius	Other: Temperature Mixture of anesthetic 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:

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

Contacts and Locations

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

Contacts

Contact: FuZhou Wang, MD	86-25-84460777 ext 3301	zfwang50@gmail.com
Contact: ShiQin Xu, MD	86-25-84460777 ext 3301	xusqnj@sina.com

Locations

China, Jiangsu
Nanjing Maternal and Child Health Care Hospital	Recruiting
Nanjing, Jiangsu, China, 210004
Contact: YuZhu Peng, MD 86-25-8446-0777 ext 1508 pyz1131@hotmail.com
Contact: XiRong Guo, MD 86-25-8446-0777 ext 1508 xrguonjmueducn@yahoo.com.cn
Sub-Investigator: YuSheng Liu, MD

Sponsors and Collaborators

Nanjing Medical University

Investigators

Study Director:

XiaoFeng Shen, MD

Nanjing Medical University

More Information

Responsible Party:	Nanjing Medical University ( XiaoFeng Shen )
Study ID Numbers:	NMU-200812-MZ32, NJFY0812009
Study First Received:	December 26, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00815022
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

Temperature
Spinal anesthesia
Cesarean section
Cephalad sensory blockade
Regional anesthesia

Study placed in the following topic categories:

Morphine
Fentanyl
Bupivacaine

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Pharmacologic Actions
Adjuvants, Anesthesia

Anesthetics, General
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 15, 2009