Intraoperative and Postoperative Effects of Tramadol and Dexamethasone Added to Washing Solution in Knee Arthroscopies

NCT ID: NCT07064993

Last Updated: 2025-11-21

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2026-09-02

Brief Summary

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To evaluate the effects of tramadol and dexamethasone added to washing solutions on postoperative nausea and vomiting, VAS score, itching and chills in knee arthroscopy cases.

Randomised, double-blind, prospective, clinical trial

Research Question(s):

1. Do tramadol and dexamethasone added to the washing solution have any effect on postoperative parameters in knee arthroscopy cases?
2. Does the postoperative efficacy change depending on the dose of tramadol and dexamethasone in the washing solution?

Translated with DeepL.com (free version)

Detailed Description

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Knee arthroscopy is a minimal surgical treatment method that allows closed intervention under anaesthesia for the diagnosis and treatment of joint disorders. The natural structure of the joints is preserved as much as possible and no unnecessary tissue damage is caused. The most important advantage is the possibility to reach every part of the joint and provide complete treatment.The aim of the study was to evaluate the effects of tramadol and dexamethasone added to washing solutions on postoperative nausea and vomiting, VAS score, itching and chills in knee arthroscopy cases.

Patients who are decided to undergo knee arthroscopy will be evaluated preoperatively by the anaesthesia outpatient clinic. Necessary information will be given and consent will be obtained. Patients will be randomised into 2 groups as study (S) and control (C) groups.

Study Group (Group S): 100 mg tramadol + 8 mg dexamethasone will be added to each 1000cc washing solution.

(tramadol max iv dose: 400 mg/day) (Dexamethasone max iv dose: 32mg/day) No any drugs will be used for control group solution For postoperative analgesia, 15mg/kg paracetamol iv will be administered to both groups as standard before extubation. The moment of being admitted to the PACU and having a RAMSAY sedation scale of 3 or less will be accepted as hour 0; 0, 3 and 6 hours VAS, nausea, vomiting, itching and chills will be evaluated.

Conditions

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Nausea and Vomitting VAS Will be Used to Assess Pain Postoperative Itching Chills

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomised, controlled, double-blind,
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Control group

Standart knee arthroscopy washing solution was used. No drugs administered

Group Type ACTIVE_COMPARATOR

Observation

Intervention Type OTHER

Routine monitoring and observation

study group

100 mg tramadol + 8 mg dexamethasone will be added to each 1000cc washing solution of the patients in the study group. (tramadol max i.v dose: 400 mg/day) dexamethasone max i.v dose: 32 mg/day)

Group Type EXPERIMENTAL

Experimental

Intervention Type PROCEDURE

Administration of tramadol and dexmethasone to arthroscopy solution

Interventions

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Observation

Routine monitoring and observation

Intervention Type OTHER

Experimental

Administration of tramadol and dexmethasone to arthroscopy solution

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All elective arthroscopy cases performed under general anaesthesia
* ASA 1-2 status
* Patients giving written consent

Exclusion Criteria

* ASA 3 and above status
* Pregnant
* Cases with advanced hepatic and renal insufficiency
* Cases with bleeding diathesis
* Cases with BMI\>35
* Cases requiring regional anaesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuzuncu Yil University

OTHER

Sponsor Role lead

Responsible Party

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Arzu Esen Tekeli

Associate Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Şükran Sevimli, PhD

Role: STUDY_CHAIR

Van Yuzuncu Yil University Ethics

Locations

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Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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19.11.2024

Identifier Type: -

Identifier Source: org_study_id

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