Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®)

NCT03050242 | Completed

• 1 other identifier: 2017-01-001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to evaluate the efficacy and safety of glycopyrrolate as an antisialagogue prior to intubation with the rigid-videostylet(Optiscope®) in the general anesthesia settings. Upper airway secretions limit the use of the videostylet during during endotracheal intubation. Therefore, in this study, patients will be allocated to either of the two groups according to the administration of glycopyrrolate and the effect of glycopyrrolate in reducing oral secretions will be assessed by the observer while intubating with the rigid-videostylet. The efficacy of the antisialagogic effect on the view during endotracheal intubation will be evaluated.

Conditions

Cholecystitis, Acute

Outcome Measures

Primary Outcomes (1)

• The degree of the secretion

  The degree of the secretion evaluation done through the OptiScope(R). It was graded by 4-point-scale. Excellent (1) : Dry. No secretion Good (2): Moist Acceptable (2): Wet. Suctioning is NOT required to intubate. Poor(4): Wet. Suctioning is required to intubate

  After an average of 1 second from the start of intubation with the OptiScope®.

Secondary Outcomes (1)

• Time to Intubate

  2 minutes after the start of intubation with the OptiScope®.

Study Arms (2)

Glycopyrrolate

EXPERIMENTAL

Glycopyrrolate 0.005mg/kg is administered intramuscularly, one hour before the surgery.

Drug: Glycopyrrolate

Control

NO INTERVENTION

No injection is conducted in this group.

Interventions

Glycopyrrolate DRUG

Intramuscular administration of glycopyrrolate 0.005mg/kg 1 hour before the surgery

Also known as: intramuscular glycopyrrolate premedication

Glycopyrrolate

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective laparoscopic cholecystectomy under general anesthesia
• aged from 19 to 65, adult patients
• american society of anesthesiologist physical status 1,2
• obtaining written informed consent

You may not qualify if:

• obese patients with body mass index above 30
• expected difficult intubation (ex. intraoral mass, history of former difficult intubation, limitation of mouth opening..)

Sponsors & Collaborators

• Eunah Cho, MD: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Related Publications (1)

• Cho EA, Hwang SH, Lee SH, Ryu KH, Kim YH. Does glycopyrrolate premedication facilitate tracheal intubation with a rigid video-stylet?: A randomized controlled trial. Medicine (Baltimore). 2018 Aug;97(32):e11834. doi: 10.1097/MD.0000000000011834.

  PMID: 30095660 DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eunah Cho, M.D.

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Fellow

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 10, 2017
• Study Start: March 13, 2017
• Primary Completion: May 18, 2017
• Study Completion: May 19, 2017
• Last Updated: May 24, 2018

Record last verified: 2018-05

Locations

KR (1)