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

• ClinicalTrials.gov Identifier: NCT03050242
• Recruitment Status: Completed
• First Posted: February 10, 2017
• Last Update Posted: May 24, 2018
• Sponsor: Eunah Cho, MD
• Information provided by (Responsible Party): Eunah Cho, MD, Kangbuk Samsung Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cholecystitis, Acute	Drug: Glycopyrrolate	Not Applicable

Detailed Description:

Recently, the newer forms of intubating devices combining video technologies were introduced. The fiberoptic stylets are useful instrumentations especially for difficult airways and limited neck mobilizations.The OptiScope® is a semi-rigid videostylet designed for endotracheal intubation. While using the device, visualization of the airway might be obscured by the secretions during its insertion. The deterioration of the view leads to intubation failure, resulting in multiple intubation attempts, longer intubating time and desaturation.Therefore, while using the Opticoscope®, proper antisialagogic preparation will be helpful.

Total 78 patients scheduled for general anesthesia aged 20-65 years and Anesthesiologists physical status (ASA) class 1 or 2 will be included. The obese patients (BMI>30) and expected difficult intubation will be excluded. The sample size was estimated based on the preliminary study. With a type Ⅰ error estimate(α) of 0.05 at 80% power, we estimated that 30 patients in each group, or 60 in total, were needed. Considering the drop-out rate of 30%, the total sample size were 78 in total. The patients will be randomly allocated to the glycopyrrolate group(G) and the control group(C). The group-G will received intramuscular glycopyrrolate 0.005mg/kg injection 1 hour before the surgery. For the group-C glycopyrrolate will not be administered. Intubation will be conducted with the OptiScope®. While intubating, the degree of the secretion will be evaluated through the OptiScope® and graded excellent, good, poor and unacceptable according to the dryness and the visualization of the vocal cord. When the vocal cord was seen without secretions, it was stated 'Excellent'. 'Good' was graded when secretions existed without the need for suctioning to visualize the vocal cord. When there were secretions and needed suctioning to clear the view, the subjects were rated 'Poor'. When intubation was failed due to poor visualization of the vocal cord despite the suctioning of the secretion, it was graded 'Unacceptable'. If the intubation is not available within 1 minute, the intubation will be done with the laryngoscope. The time to intubate will be checked by the assist anesthesiologist. The definition of the 'intubation time' is the time between the introduction of the OptiScope® into the mouth and the confirmation of the proper intubation with capnographic wave.The baseline vital signs including systolic blood pressure, mean arterial pressure, diastolic blood pressure and heart rate will be measured before the intubation and 1,3 and 5 minutes after the intubation.

The collected data will be compared with the independent t-test or Mann-Whitney-Wilcoxon test for the continuous variables. Χ2 test and Fisher's exact test will be performed for the categorical variables. Significant level will be set at 0.05.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Benefits of Intramuscular Glycopyrrolate Premedication on Intubation With Rigid-videostylet (OptiScope® PM 201, KoMAC Co., Ltd, Seoul, Republic of Korea)
• Actual Study Start Date: March 13, 2017
• Actual Primary Completion Date: May 18, 2017
• Actual Study Completion Date: May 19, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Glycopyrrolate; Glycopyrrolate 0.005mg/kg is administered intramuscularly, one hour before the surgery.	Drug: Glycopyrrolate; Intramuscular administration of glycopyrrolate 0.005mg/kg 1 hour before the surgery; Other Name: intramuscular glycopyrrolate premedication
No Intervention: Control; No injection is conducted in this group.

Outcome Measures

Primary Outcome Measures :

1. The degree of the secretion [ Time Frame: After an average of 1 second from the start of intubation with the OptiScope®. ]
   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

Secondary Outcome Measures :

1. Time to Intubate [ Time Frame: 2 minutes after the start of intubation with the OptiScope®. ]
   It is defined by the time between the introduction of the OptiScope® into the mouth and the confirmation of the proper intubation with capnographic wave.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Contacts and Locations

Locations

Korea, Republic of

Kangbuk Samsung Hospital

Seoul, Korea, Republic of, 03181

Sponsors and Collaborators

Eunah Cho, MD

Investigators

• Principal Investigator: Eunah Cho, M.D.; Kangbuk Samsung Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Eunah Cho, MD, Clinical Fellow, Kangbuk Samsung Hospital
• ClinicalTrials.gov Identifier: NCT03050242
• Other Study ID Numbers: 2017-01-001
• First Posted: February 10, 2017
• Last Update Posted: May 24, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cholecystitis; Cholecystitis, Acute; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Glycopyrrolate; Adjuvants, Anesthesia; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs