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Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

Primary Purpose

Bradycardia

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
IM atropine
IV atropine
Atropine mixed with second dose succinylcholine
IM normal saline
IV normal saline
Normal saline mixed with second dose succinylcholine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bradycardia focused on measuring Atropine, Succinycholine, Laparoscopy, Gynecology

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Occurrence of bradycardia
heart rate less than 60 per minutes or decrease more than 30% of baseline reading

Secondary Outcome Measures

Nasopharyngeal secretion
suction of Nasopharyngeal secretion (ml) during and after extubation

Full Information

First Posted
February 3, 2016
Last Updated
September 25, 2016
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02676011
Brief Title
Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery
Official Title
Prevention of Brad Arrhythmia Induced by Repeated Succinylcholine by Atropine Sulfate During Gynecological Laparoscopic Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
Keywords
Atropine, Succinycholine, Laparoscopy, Gynecology

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group D
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
IM atropine
Other Intervention Name(s)
IM atropine sulphate
Intervention Description
Atropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
IV atropine
Other Intervention Name(s)
IV atropine sulphate
Intervention Description
Atropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Atropine mixed with second dose succinylcholine
Other Intervention Name(s)
atropine sulphate with succinylcholine
Intervention Description
Atropine (0.01 mg/kg) added to the second dose succinylcholine (1mg/kg) prepared to 5 ml syringe with normal saline
Intervention Type
Drug
Intervention Name(s)
IM normal saline
Other Intervention Name(s)
Normal saline
Intervention Description
1 ml normal saline IM 30 minutes before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
IV normal saline
Other Intervention Name(s)
Normal saline
Intervention Description
IV 10 ml normal saline 3 minutes before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Normal saline mixed with second dose succinylcholine
Other Intervention Name(s)
Normal saline with succinylcholine
Intervention Description
Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline
Primary Outcome Measure Information:
Title
Occurrence of bradycardia
Description
heart rate less than 60 per minutes or decrease more than 30% of baseline reading
Time Frame
within the first 2 hours during surgery
Secondary Outcome Measure Information:
Title
Nasopharyngeal secretion
Description
suction of Nasopharyngeal secretion (ml) during and after extubation
Time Frame
within the first 4 hours during surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients 18-50 years scheduled for elective diagnostic gynecological laparoscopic surgery Exclusion Criteria: Cardiac Diabetes Mellitus Thyroid disease Any endocrine disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sayed abd elshafy, M
Organizational Affiliation
associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

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