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Clinical Trials/NCT03181672
NCT03181672UnknownNot Applicable

Influence of Stellate Ganglion Block on Tourniquet Response in Lower Limbs.

The Affiliated Hospital of Xuzhou Medical University1 site in 1 country100 target enrollmentStarted: June 2, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
heart rate

Study Overview

Brief Summary

To investigate the influence of stellate ganglion block on tourniquet response during surgery in patients undergoing elective lower limb Department of orthopedics.

Detailed Description

Select elective general anesthesia in 100 cases of lower extremity Department of orthopedics surgery patients were randomly divided into SGB group and control group, SGB group received anesthesia before the right stellate ganglion block intervention, the control group underwent right deltoid muscle injection, changes in hemodynamics in two groups were recorded in heart rate, blood pressure, and before anesthesia, after intubation 3min 1H, a tourniquet, tourniquet release before and after tourniquet release 3min, 30min, changes in blood physiological analysis. The effect of stellate ganglion block on tourniquet response during perioperative period was observed.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •American Society of anesthesiologists Grade 1-3 Patients
  • •undergoing lower limb surgery under general anesthesia
  • •should be treated with tourniquet

Exclusion Criteria

  • •Tourniquet application time is less than 1h, greater than 1.5h
  • •Abnormal coagulation function
  • •perioperative application of hormone
  • •lidocaine allergy
  • •can not cope with nerve block
  • •nerve block failure
  • •minimally invasive surgery

Arms & Interventions

Stellate ganglion block

Active Comparator

Stellate ganglion block

Intervention: Stellate ganglion block (Procedure)

control group

Placebo Comparator

Deltoid muscle injection

Intervention: control group (Procedure)

Outcomes

Primary Outcomes

heart rate

Time Frame: 2 hours in perioperative period

bpm

ET-1

Time Frame: One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet

ELISA ng/L

SOD

Time Frame: One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet

ELISA μg/L

IL-6

Time Frame: One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet

ELISA pg/ml

cTn-T

Time Frame: One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet

ELISA μg/L

blood pressure

Time Frame: 2 hours in perioperative period

mmHg

Lac

Time Frame: One minute after the radial artery puncture, the tourniquet was applied for 1 hours and the tourniquet was released 3 minutes after the tourniquet release 30 minutes

blood gas analysis mmol/L

norepinephrine

Time Frame: One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet

ELISA nmol/L

cortisol

Time Frame: One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet

ELISA ng/ml

postoperative pain

Time Frame: hour 1、hour 6、hour 24、hour 48 after operation

VAS score

MDA

Time Frame: One minute after the radial artery puncture, one minute after intubation, tourniquet application 1 hour, one minute before tourniquet, loose after a tourniquet for 3 minutes, 30 minutes after a tourniquet

ELISA nmol/ml

Secondary Outcomes

  • Complication of puncture(2 hours in perioperative period)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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