Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects

NCT ID: NCT02189655

Last Updated: 2019-11-20

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

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2021-12-31

Brief Summary

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This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.

Detailed Description

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This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.Group Control:traditional intrathecal administration; Group Diluting:Diluting with cerebrospinal fluid

Conditions

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Antishivering Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group Control

Hyperbaric bupivacaine 0.5% 2.5 mL was administered intrathecally in 30 seconds.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group Diluting with cerebrospinal fluid

Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds

Group Type EXPERIMENTAL

bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid

Intervention Type PROCEDURE

Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds

Interventions

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bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid

Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ who were scheduled for elective surgery under spinal anesthesia were enrolled.

Exclusion Criteria

* Patients with pre-operative fever (\>38℃), diabetes, , Parkinson's disease, hypo or hyperthyroidism, Raynaud's syndrome, obese patients (weight \>100 kg), patients shorter than 152 cm, those with a history of allergy to the study medications, and patients receiving vasodilators were excluded from the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Wen-fei Tan

Department of Anesthesiology, The First Hospital of CMU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Ma, M.D.,Ph.D

Role: STUDY_DIRECTOR

The First Hospital of CMU

Locations

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the First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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20140630

Identifier Type: -

Identifier Source: org_study_id

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