Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia

NCT00815022 | Completed DMC

• 2 other identifiers: NMU-200812-MZ32NJFY0812009
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Delivery

Keywords

Temperature; Spinal anesthesia; Cesarean section; Cephalad sensory blockade; Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Maximum cephalad sensory blockade to pinprick, cold and touch

  From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia

Secondary Outcomes (3)

• Velocity of the sensory blockade at identical body position

  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

  From the delivery of anesthetic mixture to 25 min after spinal anesthesia

• Time interval of the occurrence of the hypotension

  From the delivery of the anesthetic mixture to 25 min after spinal anesthesia

Study Arms (6)

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

Drug: bupivacaine/fentanyl/morphine

2

EXPERIMENTAL

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

3

EXPERIMENTAL

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

4

EXPERIMENTAL

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

5

EXPERIMENTAL

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

6

EXPERIMENTAL

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

Interventions

bupivacaine/fentanyl/morphine DRUG

Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous women
• \> 18 years and \< 45 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• XiaoFeng Shen, MD

  Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 26, 2008
• First Posted: December 29, 2008
• Study Start: December 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

CN (1)