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

NCT ID: NCT03050242

Last Updated: 2018-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-13
• Study Completion Date: 2017-05-19

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.

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.

Conditions

Cholecystitis, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Glycopyrrolate

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

Group Type: EXPERIMENTAL

Glycopyrrolate

Intervention Type: DRUG

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

Control

No injection is conducted in this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Glycopyrrolate

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

Intervention Type: DRUG

Other Intervention Names

intramuscular glycopyrrolate premedication

Eligibility 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..)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunah Cho, MD

OTHER

Sponsor Role: lead

Responsible Party

Eunah Cho, MD

Clinical Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eunah Cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

Kangbuk Samsung Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30095660 (View on PubMed)

Other Identifiers

2017-01-001

Identifier Type: -

Identifier Source: org_study_id