Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia

NCT ID: NCT00815022

Last Updated: 2014-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 20 degree celsius

Group Type ACTIVE_COMPARATOR

bupivacaine/fentanyl/morphine

Intervention Type DRUG

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

2

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 10 degree celsius

Group Type EXPERIMENTAL

bupivacaine/fentanyl/morphine

Intervention Type DRUG

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

3

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 15 degree celsius

Group Type EXPERIMENTAL

bupivacaine/fentanyl/morphine

Intervention Type DRUG

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

4

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 25 degree celsius

Group Type EXPERIMENTAL

bupivacaine/fentanyl/morphine

Intervention Type DRUG

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

5

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 30 degree celsius

Group Type EXPERIMENTAL

bupivacaine/fentanyl/morphine

Intervention Type DRUG

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

6

Mixture of anesthetic including hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg, with the temperature of 35 degree celsius

Group Type EXPERIMENTAL

bupivacaine/fentanyl/morphine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bupivacaine/fentanyl/morphine

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fu Zhou Wang

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

XiaoFeng Shen, MD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NJFY0812009

Identifier Type: -

Identifier Source: secondary_id

NMU-200812-MZ32

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dexmedetomidine for Cesarean Section
NCT02715154 COMPLETED PHASE1