Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

NCT ID: NCT02676011

Last Updated: 2016-09-27

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-05-31

Brief Summary

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Cardiac arrhythmias are a well-recognized complication of anesthesia for laparoscopy. The aim of this study was to evaluate the efficacy of atropine sulfate for prevention of brad arrhythmia induced by repeated succinylcholine during gynecological laparoscopic surgery.

Detailed Description

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120 candidates, ASA 1 in the age range 18-40 years scheduled for elective diagnostic gynecological laparoscopic surgery were randomly assigned into 4 groups to receive either atropine sulfate or normal saline solution (as placebo).

Conditions

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Bradycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Intramuscular (IM) atropine (0.01 mg/kg) (1 ml) 30 minutes before induction of anesthesia, IV normal saline 10 ml 3 minutes before induction of anesthesia and normal saline mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline

Group Type ACTIVE_COMPARATOR

IM atropine

Intervention Type DRUG

Atropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia

IV normal saline

Intervention Type DRUG

IV 10 ml normal saline 3 minutes before induction of anesthesia

Normal saline mixed with second dose succinylcholine

Intervention Type DRUG

Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline

Group B

1 ml normal saline IM 30 minutes before induction of anesthesia, intravenously (IV) atropine (0.01 mg/kg) in 10 ml 3 minutes before induction of anesthesia and normal saline mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline

Group Type ACTIVE_COMPARATOR

IV atropine

Intervention Type DRUG

Atropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia

IM normal saline

Intervention Type DRUG

1 ml normal saline IM 30 minutes before induction of anesthesia

Normal saline mixed with second dose succinylcholine

Intervention Type DRUG

Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline

Group C

IM normal saline 1 ml normal 30 minutes before induction of anesthesia, IV normal saline 10 ml 3 minutes before induction of anesthesia and 1mg/kg atropine mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline

Group Type ACTIVE_COMPARATOR

Atropine mixed with second dose succinylcholine

Intervention Type DRUG

Atropine (0.01 mg/kg) added to the second dose succinylcholine (1mg/kg) prepared to 5 ml syringe with normal saline

IM normal saline

Intervention Type DRUG

1 ml normal saline IM 30 minutes before induction of anesthesia

IV normal saline

Intervention Type DRUG

IV 10 ml normal saline 3 minutes before induction of anesthesia

Group D

IM normal saline 1 ml normal 30 minutes before induction of anesthesia, IV normal saline 10 ml 3 minutes before induction of anesthesia and normal saline mixed with second dose succinylcholine (1mg/kg) in 5 ml syringe with normal saline

Group Type PLACEBO_COMPARATOR

IM normal saline

Intervention Type DRUG

1 ml normal saline IM 30 minutes before induction of anesthesia

IV normal saline

Intervention Type DRUG

IV 10 ml normal saline 3 minutes before induction of anesthesia

Normal saline mixed with second dose succinylcholine

Intervention Type DRUG

Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline

Interventions

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IM atropine

Atropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia

Intervention Type DRUG

IV atropine

Atropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia

Intervention Type DRUG

Atropine mixed with second dose succinylcholine

Atropine (0.01 mg/kg) added to the second dose succinylcholine (1mg/kg) prepared to 5 ml syringe with normal saline

Intervention Type DRUG

IM normal saline

1 ml normal saline IM 30 minutes before induction of anesthesia

Intervention Type DRUG

IV normal saline

IV 10 ml normal saline 3 minutes before induction of anesthesia

Intervention Type DRUG

Normal saline mixed with second dose succinylcholine

Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline

Intervention Type DRUG

Other Intervention Names

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IM atropine sulphate IV atropine sulphate atropine sulphate with succinylcholine Normal saline Normal saline Normal saline with succinylcholine

Eligibility Criteria

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Inclusion Criteria

* Female patients 18-50 years scheduled for elective diagnostic gynecological laparoscopic surgery

Exclusion Criteria

* Cardiac
* Diabetes Mellitus
* Thyroid disease
* Any endocrine disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sayed Kaoud Abd-Elshafy

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sayed abd elshafy, M

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

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Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB000087133

Identifier Type: -

Identifier Source: org_study_id

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