Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2024-07-31

Brief Summary

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Post operative sore throat after general anesthesia with endotracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. The investigators want to study the effect of tramadol on postoperative sore throat in general anesthesia with endotracheal intubation.

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Detailed Description

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Design: A prospective, randomized, controlled study. Setting: Single-center university hospital. Participants: The study included 168 patients undergoing thyroid surgery under general anesthesia with endotracheal intubation.

Interventions: The patients were allocated randomly into the following 3 groups: the control group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and another 5ml of normal saline was injected intravenously when the incision was washed and sutured；the pre-tramadol group: patients will be injected intravenously 5ml of tramadol (1mg / kg) 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured. the post-tramadol group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and 5ml of tramadol (1mg / kg) was injected intravenously when the incision was washed and sutured. Postoperatively, all patients will receive standard treatment.

Conditions

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Post-operative Sore Throat Intubation Intratracheal Thyroid Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The anesthesia provider will be blinded to the intervention group allocation. All patients will be blinded. The primary investigator will be blinded. The resident researcher who will be the outcome assessor will also be blinded. The care provider will be blinded.

Study Groups

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Placebo group

5ml normal saline was injected intravenously 15 minutes before anesthesia and 5ml normal saline was injected intravenously when the incision was washed and sutured.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

pre-tramadol group: Normal Saline will be injected intravenously when the incision was washed and sutured.

post-tramadol group: Normal Saline will be injected intravenously 15 minutes before anesthesia.

pre-tramadol group

5ml of tramadol containing 1mg / kg was injected intravenously 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured.

Group Type EXPERIMENTAL

Tramadol hydrochloride

Intervention Type DRUG

pre-tramadol group: 1mg/kg of tramadol will be intravenously injected 15 minutes before anesthesia.

post-tramadol group: 1mg/kg of tramadol will be intravenously injected when the incision was washed and sutured.

post-tramadol group

5ml of normal saline was injected intravenously 15 minutes before anesthesia and 5ml of tramadol containing 1mg / kg was injected intravenously when the incision was washed and sutured.

Group Type ACTIVE_COMPARATOR

Tramadol hydrochloride

Intervention Type DRUG

pre-tramadol group: 1mg/kg of tramadol will be intravenously injected 15 minutes before anesthesia.

post-tramadol group: 1mg/kg of tramadol will be intravenously injected when the incision was washed and sutured.

Interventions

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Tramadol hydrochloride

pre-tramadol group: 1mg/kg of tramadol will be intravenously injected 15 minutes before anesthesia.

post-tramadol group: 1mg/kg of tramadol will be intravenously injected when the incision was washed and sutured.

Intervention Type DRUG

Normal Saline

pre-tramadol group: Normal Saline will be injected intravenously when the incision was washed and sutured.

post-tramadol group: Normal Saline will be injected intravenously 15 minutes before anesthesia.

Intervention Type OTHER

Other Intervention Names

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Tramadol

Eligibility Criteria

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Inclusion Criteria

\- Female with American Society of Anesthesiologists (ASA) physical status I-II; Elective thyroidectomy(non-endoscopic) with endotracheal intubation; The patient signed the consent form.

Exclusion Criteria

\- History of thyroid surgery A history of preoperative sore throat; Pregnancy; Retrosternal goiter; Thyroid tumor invading trachea need trachea reconstruction; Potentially difficult airway; Clinical diagnosis of chronic sore throat; Clinical diagnosis of psychosis; Tracheotomy after operation； Transfer to intensive care unit after operation； Contraindications to tramadol； Body mass index (BMI) \> 30kg/m\^2.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No