NCT04563260

Brief Summary

The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female patients who receive the palonosetron or not.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

October 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

September 15, 2020

Last Update Submit

May 10, 2021

Conditions

Gallbladder Diseases

Outcome Measures

Primary Outcomes (1)

  • optimal Ce of remifentanil

    Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia

    From the end of surgery until the time of endotracheal extubation, about 20 minutes

Study Arms (2)

Control group

PLACEBO COMPARATOR

Control group receives the intravenous normal saline 2 mL.

Drug: Normal saline injection

Palonosetron group

EXPERIMENTAL

Palonosetron group receives the intravenous palonosetron 1.5 mL (0.075 mg) + normal saline 0.5 mL.

Drug: Palonosetron Injection [Aloxi]

Interventions

Normal saline injectionDRUG

Normal saline 2 mL, intravenous injection

Control group
Palonosetron Injection [Aloxi]DRUG

Palonosetron 1.5 mL (0.075 mg) + Normal saline 0.5 mL, intravenous injection

Palonosetron group

Eligibility Criteria

Age19 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laparoscopic cholecystectomy under general anesthesia

You may not qualify if:

  • BMI \> 30 kg/m2, respiratory infection, uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, South Korea

Location

MeSH Terms

Conditions

Gallbladder Diseases

Interventions

Saline SolutionPalonosetron

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsQuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 24, 2020

Study Start

October 7, 2020

Primary Completion

March 19, 2021

Study Completion

March 19, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations

KR(1)