Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®)
Primary Purpose
Cholecystitis, Acute
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Glycopyrrolate
Sponsored by
About this trial
This is an interventional supportive care trial for Cholecystitis, Acute
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..)
Sites / Locations
- Kangbuk Samsung Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Glycopyrrolate
Control
Arm Description
Glycopyrrolate 0.005mg/kg is administered intramuscularly, one hour before the surgery.
No injection is conducted in this group.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to Intubate
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03050242
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
May 18, 2017 (Actual)
Study Completion Date
May 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eunah Cho, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Acute
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glycopyrrolate
Arm Type
Experimental
Arm Description
Glycopyrrolate 0.005mg/kg is administered intramuscularly, one hour before the surgery.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No injection is conducted in this group.
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Other Intervention Name(s)
intramuscular glycopyrrolate premedication
Intervention Description
Intramuscular administration of glycopyrrolate 0.005mg/kg 1 hour before the surgery
Primary Outcome Measure Information:
Title
The degree of the secretion
Description
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
Time Frame
After an average of 1 second from the start of intubation with the OptiScope®.
Secondary Outcome Measure Information:
Title
Time to Intubate
Description
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.
Time Frame
2 minutes after the start of intubation with the OptiScope®.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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..)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eunah Cho, M.D.
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30095660
Citation
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.
Results Reference
derived
Learn more about this trial
Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®)
We'll reach out to this number within 24 hrs