A Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-26

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Post Operative Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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dexmedetomidine infusion group

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

Group Type ACTIVE_COMPARATOR

dexmedetomidine infusion

Intervention Type DRUG

dexmedetomidine as anaesthetic adjuvant

remifentanil infusion group

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

Group Type ACTIVE_COMPARATOR

remifentanil infusion

Intervention Type DRUG

remifentanil as anaesthetic adjuvant

Interventions

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dexmedetomidine infusion

dexmedetomidine as anaesthetic adjuvant

Intervention Type DRUG

remifentanil infusion

remifentanil as anaesthetic adjuvant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No