Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

Assiut University

Status and phase: Completed; Phase 2

Conditions: Bradycardia

Treatments: Drug: Normal saline mixed with second dose succinylcholine; Drug: IM normal saline; Drug: IV normal saline; Drug: Atropine mixed with second dose succinylcholine; Drug: IM atropine; Drug: IV atropine

Study type: Interventional

Funder types: Other

Identifiers

NCT02676011

IRB000087133

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Group A

Active Comparator group

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

Treatment:

Drug: IM atropine

Drug: IV normal saline

Drug: Normal saline mixed with second dose succinylcholine

Group B

Active Comparator group

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

Treatment:

Drug: IV atropine

Drug: IM normal saline

Drug: Normal saline mixed with second dose succinylcholine

Group C

Active Comparator group

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

Treatment:

Drug: Atropine mixed with second dose succinylcholine

Drug: IV normal saline

Drug: IM normal saline

Group D

Placebo Comparator group

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

Treatment:

Drug: IV normal saline

Drug: IM normal saline

Drug: Normal saline mixed with second dose succinylcholine