NCT02732093

Brief Summary

In this study investigators will evaluate the effect of stellate ganglion block on stress response of intubation in comparison to traditional antistress measures in adult patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

April 5, 2016

Last Update Submit

April 7, 2016

Conditions

IntubationStellate Ganglion

Outcome Measures

Primary Outcomes (1)

  • heart rate

    measured in beat/min.

    5 minutes

Secondary Outcomes (1)

  • mean arterial blood pressure

    5 minutes

Study Arms (2)

stellate block

ACTIVE COMPARATOR

patients in this arm will receive ultrasonographic guided left stellate block with 6 ml of lidocaine 2% after routine induction of general anesthesia and before endotracheal intubation

Procedure: stellate blockDrug: lidocaine 2%

control

PLACEBO COMPARATOR

patients in this arm will receive ultrasonographic guided left stellate block with 6 ml normal saline (Na.Cl 0.9%) (control group) after routine induction of general anesthesia and before endotracheal intubation

Procedure: stellate blockDrug: Na.Cl 0.9% (placebo)

Interventions

stellate blockPROCEDURE
Also known as: cervicothoracic ganglion block
controlstellate block
Na.Cl 0.9% (placebo)DRUG
control
lidocaine 2%DRUG
stellate block

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective surgery
  • General anesthesia with endotracheal intubation
  • ASA I/II

You may not qualify if:

  • Pregnancy
  • Hypersensitivity to local anesthetics
  • Coagulopathy
  • Infection at site of injection
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospitals

Asyut, Asyut Governorate, 71515, Egypt

Location

Study Officials

  • abdelraheem Elawamy, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelraheem Elawamy, MD

CONTACT

00201000032655arawamyyy@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 8, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

Locations

EG(1)