Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

Study Overview
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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).

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

Conditions
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Bradycardia

Intervention / Treatment
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* Drug: IM atropine
* Drug: IV atropine
* Drug: Atropine mixed with second dose succinylcholine
* Drug: IM normal saline
* Drug: IV normal saline
* Drug: Normal saline mixed with second dose succinylcholine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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<br>* Atropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia<br>* Other names: IM atropine sulphate;Drug: IV normal saline<br>* IV 10 ml normal saline 3 minutes before induction of anesthesia<br>* Other names: Normal saline;Drug: Normal saline mixed with second dose succinylcholine<br>* Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline<br>* Other names: Normal saline with succinylcholine;|
| Active Comparator: Group B<br>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: IV atropine<br>* Atropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia<br>* Other names: IV atropine sulphate;Drug: IM normal saline<br>* 1 ml normal saline IM 30 minutes before induction of anesthesia<br>* Other names: Normal saline;Drug: Normal saline mixed with second dose succinylcholine<br>* Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline<br>* Other names: Normal saline with succinylcholine;|
| Active Comparator: Group C<br>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: Atropine mixed with second dose succinylcholine<br>* Atropine (0.01 mg/kg) added to the second dose succinylcholine (1mg/kg) prepared to 5 ml syringe with normal saline<br>* Other names: atropine sulphate with succinylcholine;Drug: IM normal saline<br>* 1 ml normal saline IM 30 minutes before induction of anesthesia<br>* Other names: Normal saline;Drug: IV normal saline<br>* IV 10 ml normal saline 3 minutes before induction of anesthesia<br>* Other names: Normal saline;|
| Placebo Comparator: Group D<br>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: IM normal saline<br>* 1 ml normal saline IM 30 minutes before induction of anesthesia<br>* Other names: Normal saline;Drug: IV normal saline<br>* IV 10 ml normal saline 3 minutes before induction of anesthesia<br>* Other names: Normal saline;Drug: Normal saline mixed with second dose succinylcholine<br>* Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline<br>* Other names: Normal saline with succinylcholine;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atropine, Succinycholine, Laparoscopy, Gynecology