Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

Phase 2

Completed

• Conditions: Bradycardia
• Interventions: Drug: Atropine mixed with second dose succinylcholine; Drug: IV atropine; Drug: IM atropine; Drug: IV normal saline; Drug: IM normal saline; Drug: Normal saline mixed with second dose succinylcholine

• Registration Number: NCT02676011
• Lead Sponsor: Assiut University

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).

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-25
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Atropine mixed with second dose succinylcholine	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 B	IV atropine	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 A	Normal saline mixed with second dose succinylcholine	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 D	Normal saline mixed with second dose succinylcholine	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 A	IM atropine	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 A	IV normal saline	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 B	IM 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
Group C	IV 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
Group D	IV 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
Group B	Normal saline mixed with second dose succinylcholine	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 C	IM 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
Group D	IM 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

Primary Outcome Measures

Name	Time	Method
Occurrence of bradycardia	within the first 2 hours during surgery	heart rate less than 60 per minutes or decrease more than 30% of baseline reading

Secondary Outcome Measures

Name	Time	Method
Nasopharyngeal secretion	within the first 4 hours during surgery	suction of Nasopharyngeal secretion (ml) during and after extubation

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt