An interventional study of Glycopyrrolate in Cholecystitis, Acute, sponsored by Eunah Cho, MD. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-24.
Sponsored by Eunah Cho, MD · Not applicable, Interventional, and Supportive care
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.
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.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 78 is close to the median of 86 across 167 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →Eunah Cho, MD is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Glycopyrrolate 0.005mg/kg is administered intramuscularly, one hour before the surgery.
Drug: Glycopyrrolate
No injection is conducted in this group.
Intramuscular administration of glycopyrrolate 0.005mg/kg 1 hour before the surgery
Also known as: intramuscular glycopyrrolate premedication
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
Time frame: After an average of 1 second from the start of intubation with the OptiScope®.
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.
Time frame: 2 minutes after the start of intubation with the OptiScope®.
Plan to share: Undecided
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Eunah Cho, MD