Dexmedetomidine on Tourniquet Induced -Systemic Effects

NCT04307290 | Completed Phase 4

• 1 other identifier: WonkwangUH6
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Eighty patients were randomly assigned to either control (CON) or dexmedetomidine (DEX) group. DEX group received a loading dose of 0.5 µg/ kg of intravenous dexmedetomidine over 10 minutes, followed by a continuous infusion of 0.5 µg/kg/h until completion of the surgery. CON group received the same calculated volume of normal saline. Pain outcomes, metabolic and coagulative changes after tourniquet application, and after tourniquet release were investigated.

Conditions

Arthropathy of Knee; Spinal Anesthesia; Tourniquet; Ischemia-reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• total PCA volume consumed

  patient-controlled analgesia (PCA) pump containing fentanyl 1000 μg, ketorolac 150 mg, and ramosetron 0.6 mg in a total volume of 150 mL of saline was set to deliver a basal infusion of 2 mL/h and bolus doses of 1 mL, with a 15-min lockout period for postoperative analgesia.

  for 48 hours after surgery

Secondary Outcomes (5)

• hemodynamic variable

  baseline, 10 min, 30 min, 60min after tourniquet application and 10 min after tourniquet release

• heart rate (hemodynamic variable)

  baseline, 10 min, 30 min, 60min after tourniquet application and 10 min after tourniquet release

• Number of participants with metabolic variables

  baseline, 10 min after tourniquet release

• coagulative variable

  baseline, 10 min after tourniquet release

• body temperature

  at 1 min just before the start of spinal anesthesia as a baseline and at 10 min after tourniquet release.

Study Arms (2)

DEX group

EXPERIMENTAL

received intravenous dexmedetomidine (0.5 μg/kg bolus over 10 minutes, followed by 0.5 μg/kg/h infusion from 10 min before the start of surgery to the end of surgery

Drug: Dexmedetomidine Hydrochloride, or Saline

CON group

PLACEBO COMPARATOR

received an equivalent volume of normal saline bolus and infusion as placebo until the end of surgery.

Drug: Dexmedetomidine Hydrochloride, or Saline

Interventions

Dexmedetomidine Hydrochloride, or Saline DRUG

drug infusion from 10 min before the start of surgery to the end of surgery

Also known as: precedex

CON group; DEX group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged between 20 and 80 years, American Society of Anesthesiologists (ASA) physical status class I-III, who were scheduled to undergo elective TKA

You may not qualify if:

• Patients with history of rheumatoid arthritis, diabetes mellitus, hepatic or renal disease, allergy to drug being studied, heart block greater than first degree, left ventricle ejection fraction \< 55%, or chronic administration of anti-inflammatory drugs, or opioids were excluded. Patients with tourniquet times of less than 60 minutes or longer than 150 minutes or with conversion to general anesthesia during surgery

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

WonwangUH

Iksan, Jeollabuk-do, 570-711, South Korea

Location

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization sequence was created using Stata 9.0 (Stata Corp, College Station, TX, USA) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 4. Assignments were concealed in sealed envelopes. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups: DEX group (n = 40) received intravenous dexmedetomidine (0.5 μg/kg bolus over 10 minutes, followed by 0.5 μg/kg/h infusion from 10 min before the start of surgery to the end of surgery), and CON group (n = 40) received an equivalent volume of normal saline bolus and infusion as placebo until the end of surgery. Patients, attending anesthesiologists responsible for patient care, and nurses were all blinded to the anesthetic agent during the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D., Ph.D.

Model Details: dexmedetomidine (0.5 μg/kg bolus over 10 minutes, followed by 0.5 μg/kg/h infusion from 10 min before the start of surgery to the end of surgery), and CON group (n = 40) received an equivalent volume of normal saline bolus and infusion as placebo until the end of surgery.

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 13, 2020
• Study Start: February 3, 2020
• Primary Completion: February 10, 2020
• Study Completion: March 5, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)