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

Yuzuncu Yil University

Status: Active, not recruiting

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

Treatments: Procedure: Experimental; Other: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT07064993

19.11.2024

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Control group

Active Comparator group

Description:

Standart knee arthroscopy washing solution was used. No drugs administered

Treatment:

Other: Observation

study group

Experimental group

Description:

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)

Treatment:

Procedure: Experimental