Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

Bradycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676011
• Other study ID #: IRB000087133
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2016
• Last updated: September 25, 2016
• Start date: February 2016
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bradycardia

Intervention

Drug:
• IM atropine
Atropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia
• IV atropine
Atropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia
• 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
• IM normal saline
1 ml normal saline IM 30 minutes before induction of anesthesia
• IV normal saline
IV 10 ml normal saline 3 minutes before induction of anesthesia
• Normal saline mixed with second dose succinylcholine
Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Nasopharyngeal secretion	suction of Nasopharyngeal secretion (ml) during and after extubation	within the first 4 hours during surgery	Yes