Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

September 25, 2016 updated by: Sayed Kaoud Abd-Elshafy, Assiut University

Prevention of Brad Arrhythmia Induced by Repeated Succinylcholine by Atropine Sulfate During Gynecological Laparoscopic Surgery: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Cardiac
  • Diabetes Mellitus
  • Thyroid disease
  • Any endocrine disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: IM atropine
Atropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia
Other Names:
  • IM atropine sulphate
Drug: IV normal saline
IV 10 ml normal saline 3 minutes before induction of anesthesia
Other Names:
  • Normal saline
Drug: Normal saline mixed with second dose succinylcholine
Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline
Other Names:
  • Normal saline with succinylcholine
Active Comparator: 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
Drug: Normal saline mixed with second dose succinylcholine
Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline
Other Names:
  • Normal saline with succinylcholine
Drug: IV atropine
Atropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia
Other Names:
  • IV atropine sulphate
Drug: IM normal saline
1 ml normal saline IM 30 minutes before induction of anesthesia
Other Names:
  • Normal saline
Active Comparator: 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
Drug: IV normal saline
IV 10 ml normal saline 3 minutes before induction of anesthesia
Other Names:
  • Normal saline
Drug: IM normal saline
1 ml normal saline IM 30 minutes before induction of anesthesia
Other Names:
  • Normal saline
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
Other Names:
  • atropine sulphate with succinylcholine
Placebo Comparator: 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
Drug: IV normal saline
IV 10 ml normal saline 3 minutes before induction of anesthesia
Other Names:
  • Normal saline
Drug: Normal saline mixed with second dose succinylcholine
Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline
Other Names:
  • Normal saline with succinylcholine
Drug: IM normal saline
1 ml normal saline IM 30 minutes before induction of anesthesia
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of bradycardia
Time Frame: within the first 2 hours during surgery
heart rate less than 60 per minutes or decrease more than 30% of baseline reading
within the first 2 hours during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasopharyngeal secretion
Time Frame: within the first 4 hours during surgery
suction of Nasopharyngeal secretion (ml) during and after extubation
within the first 4 hours during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: sayed abd elshafy, M, Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 25, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB000087133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bradycardia

Clinical Trials on IM atropine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe