Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

NCT02676011 | Completed Phase 2 DMC

• 1 other identifier: IRB000087133
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bradycardia

Keywords

Atropine; Succinycholine; Laparoscopy; Gynecology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Nasopharyngeal secretion

  within the first 4 hours during surgery

Study Arms (4)

Group A

ACTIVE COMPARATOR

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; Drug: IV normal saline; Drug: Normal saline mixed with second dose succinylcholine

Group B

ACTIVE COMPARATOR

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; Drug: IM normal saline; Drug: Normal saline mixed with second dose succinylcholine

Group C

ACTIVE COMPARATOR

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; Drug: IM normal saline; Drug: IV normal saline

Group D

PLACEBO COMPARATOR

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; Drug: IV normal saline; Drug: Normal saline mixed with second dose succinylcholine

Interventions

IM atropine DRUG

Atropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia

Also known as: IM atropine sulphate

Group A

IV atropine DRUG

Atropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia

Also known as: IV atropine sulphate

Group B

Atropine mixed with second dose succinylcholine DRUG

Atropine (0.01 mg/kg) added to the second dose succinylcholine (1mg/kg) prepared to 5 ml syringe with normal saline

Also known as: atropine sulphate with succinylcholine

Group C

IM normal saline DRUG

1 ml normal saline IM 30 minutes before induction of anesthesia

Also known as: Normal saline

Group B; Group C; Group D

IV normal saline DRUG

IV 10 ml normal saline 3 minutes before induction of anesthesia

Also known as: Normal saline

Group A; Group C; Group D

Normal saline mixed with second dose succinylcholine DRUG

Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline

Also known as: Normal saline with succinylcholine

Group A; Group B; Group D

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Conditions

Bradycardia

Interventions

Atropine; Succinylcholine; Saline Solution

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• sayed abd elshafy, M

  associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 5, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

EG (1)