NCT05345574

Brief Summary

This study was performed to compare the effect of dexmedetomidine and remifentanil on the incidence and severity of postoperative sore throat in patients undergoing spinal surgery in the prone position who are at risk of developing postoperative sore throat.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 26, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

3.9 years

First QC Date

April 19, 2022

Last Update Submit

April 19, 2022

Conditions

Post Operative Sore Throat

Outcome Measures

Primary Outcomes (4)

  • incidence of postoperative sore throat at rest

    0=none; 1=occur

    1 hour after surgery

  • incidence of postoperative sore throat at swallowing

    0=none; 1=occur

    1 hour after surgery

  • severity of postoperative sore throat at rest

    4-point scale (0=none; 1=mild; 2=moderate; 3=severe)

    1 hour after surgery

  • severity of postoperative sore throat at swallowing

    4-point scale (0=none; 1=mild; 2=moderate; 3=severe)

    1 hour after surgery

Study Arms (2)

dexmedetomidine infusion group

ACTIVE COMPARATOR

dexmedetomidine infusion (loading dose of 1 ㎍/kg over 10 min and continuous infusion of 0.3-0.6 ㎍/kg/h) during the surgery

Drug: dexmedetomidine infusion

remifentanil infusion group

ACTIVE COMPARATOR

remifentanil of 0.05 ㎍/kg/h during induction, followed by remifentanil infusion (0.05-0.3 ㎍/kg/h) during the surgery

Drug: remifentanil infusion

Interventions

dexmedetomidine infusionDRUG

dexmedetomidine as anaesthetic adjuvant

dexmedetomidine infusion group
remifentanil infusionDRUG

remifentanil as anaesthetic adjuvant

remifentanil infusion group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status classification I and II
  • Undergoing lumbar spine surgery in prone position

You may not qualify if:

  • Pre-existing sore throat, hoarseness, or upper respiratory tract infection
  • Allergy to the study drugs
  • Anticipated difficult airways
  • More than two attempts at intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eun kyung Choi

Daegu, Korea (the Republic Of), 42415, South Korea

RECRUITING

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
Professor

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 26, 2022

Study Start

December 26, 2018

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

April 26, 2022

Record last verified: 2022-04

Locations

KR(1)