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Completed

NCT Number: NCT02676011

Brad Arrhythmia Induced by Repeated Succinylcholine During Gynecological Laparoscopic Surgery

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

IM atropine

Drug

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

Other names: IM atropine sulphate

IV atropine

Drug

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

Other names: IV atropine sulphate

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

Other names: atropine sulphate with succinylcholine

IM normal saline

Drug

1 ml normal saline IM 30 minutes before induction of anesthesia

Other names: Normal saline

IV normal saline

Drug

IV 10 ml normal saline 3 minutes before induction of anesthesia

Other names: Normal saline

Normal saline mixed with second dose succinylcholine

Drug

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

Other names: Normal saline with succinylcholine

Primary outcomes

  1. Occurrence of bradycardia

    Time frame: within the first 2 hours during surgery

    heart rate less than 60 per minutes or decrease more than 30% of baseline reading

Secondary outcomes

  1. Nasopharyngeal secretion

    Time frame: within the first 4 hours during surgery

    suction of Nasopharyngeal secretion (ml) during and after extubation

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2016
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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