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

Brief Title

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

Official Title

Benefits of Intramuscular Glycopyrrolate Premedication on Intubation With Rigid-videostylet (OptiScope® PM 201, KoMAC Co., Ltd, Seoul, Republic of Korea)

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.
    

Study Type

Interventional

Primary Outcome

The degree of the secretion

Secondary Outcome

 Time to Intubate

Condition

Cholecystitis, Acute

Intervention

Glycopyrrolate

Study Arms / Comparison Groups

 Glycopyrrolate

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

78

Start Date

March 13, 2017

Completion Date

May 19, 2017

Primary Completion Date

May 18, 2017

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..)
      

Gender

All

Ages

19 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Eunah Cho, M.D., , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT03050242

Organization ID

2017-01-001

Responsible Party

Sponsor-Investigator

Study Sponsor

Eunah Cho, MD

Study Sponsor

Eunah Cho, M.D., Principal Investigator, Kangbuk Samsung Hospital

Verification Date

May 2018