NCT03259672

Brief Summary

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 21, 2017

Last Update Submit

August 21, 2017

Conditions

Hip Arthroplasty

Keywords

intubationpharyngitisremifentanil

Outcome Measures

Primary Outcomes (1)

  • Number of participants with postoperative sore throat

    At 24 hr

Secondary Outcomes (9)

  • Number of participants with postoperative sore throat

    At 0, 2, 4 and 24 hr

  • Number of participants with postoperative hoarseness

    At 0, 2, 4 and 24 hr

  • Number of participants with postoperative cough

    At 0, 2, 4 and 24 hr

  • Number of participants with postoperative nausea

    At 0, 2, 4 and 24 hr

  • Number of participants with postoperative vomiting

    At 0, 2, 4 and 24 hr

  • +4 more secondary outcomes

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR
Drug: Sevoflurane

Desflurane

EXPERIMENTAL
Drug: Desflurane

Interventions

SevofluraneDRUG

Sevoflurane was used as a maintenance anesthetic agent.

Sevoflurane
DesfluraneDRUG

Desflurane was used as a maintenance anesthetic agent.

Desflurane

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • Patients scheduled for general anesthesia with endotracheal intubation

You may not qualify if:

  • Difficult airway
  • Friable teeth
  • Rapid sequence induction
  • Recent sore throat
  • Recent upper respiratory infection
  • Asthma
  • Chronic obstructive pulmonary disease
  • Chronic cough
  • Arrhythmia
  • Coronary disease
  • Heart failure
  • Pregnancy
  • Allergy to sevoflurane
  • Allergy to desflurane
  • Fever after halogenated anesthetics
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pharyngitis

Interventions

SevofluraneDesflurane

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Design

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

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 24, 2017

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

November 1, 2018

Last Updated

August 24, 2017

Record last verified: 2017-08