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Dexmedetomidine on Tourniquet Induced -Systemic Effects

Primary Purpose

Arthropathy of Knee, Spinal Anesthesia, Tourniquet

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride, or Saline
Sponsored by
Wonkwang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Knee

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • WonwangUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DEX group

CON group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

hemodynamic variable
Systolic blood pressure ((mmHg)), diastolic blood pressure ((mmHg)), mean arterial blood pressure ((mmHg)) were monitored every five minutes until the end of surgery.
heart rate (hemodynamic variable)
heart rate (beats/min) was monitored every five minutes until the end of surgery.
Number of participants with metabolic variables
5 mL of blood samples were extracted through radial artery and then 1 mL were collected in the heparinized syringe; following this, the remaining blood samples were immediately sent through the pneumatic tube system, guaranteeing their processing in the least amount of time possible, not greater than 5 minutes by institutional standards. The metabolic variables included pH, lactate(Mm/L), calcium(mg/dl), potassium(mEq/L), bicarbonate(Mm/L), CO2(mmHg)
coagulative variable
coagulative change included antithrombin III activity (%).
body temperature
Tympanic temperature measurements were made using Braun Thermoscan inserted into the auditory canal

Full Information

First Posted
March 9, 2020
Last Updated
March 12, 2020
Sponsor
Wonkwang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04307290
Brief Title
Dexmedetomidine on Tourniquet Induced -Systemic Effects
Official Title
The Impact of Dexmedetomidine on Tourniquet Induced -Systemic Effects in Total Knee Arthroplasty Under Spinal Anesthesia-prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonkwang University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A total of 80 patients aged between 20 and 80 years, American Society of Anesthesiologists (ASA) physical status class I-III, who were scheduled to undergo elective TKA were enrolled in this study. 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 were also excluded. Randomization 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. Anesthesia and perioperative care Standard monitoring included electrocardiography, noninvasive arterial blood pressure monitoring, and pulse oximetry. All patients received spinal anesthesia performed by an attending anesthesiologist and 500 mL Ringer's lactate solution was administered for hydration before spinal anesthesia. Spinal anesthesia was performed in the lateral decubitus position with the operative knee uppermost. These patients received an intrathecal injection of 0.5% bupivacaine 15 mg in 5% glucose at the level of L4-5 via using a 25-gauge needle. Patients were then turned to the supine position and the level of sensory block evaluated by pinprick. Peak level of sensory block, sensory dermatome at tourniquet pain, time between tourniquet application and onset of pain, and tourniquet pain were performed by an independent researcher at 5, 10, 15 and 20 min after the spinal injection and then at 10-minutes intervals until the complete resolution of the sensory block. The affected extremity in all patients was exsanguinated with an Esmarch bandage, and a tourniquet was applied at a pressure of 300 mmHg during surgery. When a poorly localized, diffuse pain is felt by the patient at variable times after tourniquet inflation, despite adequate sensory blockade during surgery, it was considered to be induced by the tourniquet if it was unrelated to the surgical field, described as tourniquet pain in the affected extremity. Supplemental analgesia with intravenous fentanyl 100 μg was to be administered if any patient experienced tourniquet pain at any time during the procedure. General anesthesia would be induced if intravenous fentanyl supplementation was insufficient. The need for supplemental intravenous fentanyl and any conversion to general anesthesia were recorded. When intraoperative bleeding occurred, volume replacement with Ringer's lactate solution was managed according to the decision of an attending anesthesiologist instead of blood products. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) and heart rate (HR) were monitored every five minutes until the end of surgery. Hypotension was defined as a 30% reduction of basal MAP, which was treated with ephedrine 5 mg iv. When the HR was <50 beats/minute (bradycardia), glycopyrrolate 0.2 mg was administered intravenously. Before the start of surgery, femoral nerve block to reduce postoperative pain were performed using a bolus of 20 mL of ropivacaine 0.75%. Concurrently, 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. PCA volume consumed at 24 and 48 hours after surgery and total PCA volume consumed for 48 hr after surgery. Postoperative pain intensity at rest was measured using a 100 mm linear visual analog scale (VAS). The VAS score for pain at rest was measured at 24 and 48 hours after surgery. Fentanyl 100 μg was administered for a pain VAS ≥ 50 or ketorolac 30 mg was given for a pain VAS < 50 or upon patient request. Measurements of metabolic, coagulative and temperature changes. The arterial blood samples were obtained from a radial artery at 1 minute just before the start of spinal anesthesia as a baseline and at 10 min after tourniquet release. 5 mL of blood samples were extracted through radial artery and then 1 mL were collected in the heparinized syringe; following this, the remaining blood samples were immediately sent through the pneumatic tube system, guaranteeing their processing in the least amount of time possible, not greater than 5 minutes by institutional standards. The metabolic variables included pH, lactate, calcium, potassium, bicarbonate, CO2, base excess and coagulative change included antithrombin III activity. Tympanic temperature measurements were made using Braun Thermoscan (Thermoscan Inc., San Diego, CA) inserted into the auditory canal at 1 minute just before the start of spinal anesthesia as a baseline and at 10 minutes after tourniquet release

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee, Spinal Anesthesia, Tourniquet, Ischemia-reperfusion Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEX group
Arm Type
Experimental
Arm Description
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
Arm Title
CON group
Arm Type
Placebo Comparator
Arm Description
received an equivalent volume of normal saline bolus and infusion as placebo until the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride, or Saline
Other Intervention Name(s)
precedex
Intervention Description
drug infusion from 10 min before the start of surgery to the end of surgery
Primary Outcome Measure Information:
Title
total PCA volume consumed
Description
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.
Time Frame
for 48 hours after surgery
Secondary Outcome Measure Information:
Title
hemodynamic variable
Description
Systolic blood pressure ((mmHg)), diastolic blood pressure ((mmHg)), mean arterial blood pressure ((mmHg)) were monitored every five minutes until the end of surgery.
Time Frame
baseline, 10 min, 30 min, 60min after tourniquet application and 10 min after tourniquet release
Title
heart rate (hemodynamic variable)
Description
heart rate (beats/min) was monitored every five minutes until the end of surgery.
Time Frame
baseline, 10 min, 30 min, 60min after tourniquet application and 10 min after tourniquet release
Title
Number of participants with metabolic variables
Description
5 mL of blood samples were extracted through radial artery and then 1 mL were collected in the heparinized syringe; following this, the remaining blood samples were immediately sent through the pneumatic tube system, guaranteeing their processing in the least amount of time possible, not greater than 5 minutes by institutional standards. The metabolic variables included pH, lactate(Mm/L), calcium(mg/dl), potassium(mEq/L), bicarbonate(Mm/L), CO2(mmHg)
Time Frame
baseline, 10 min after tourniquet release
Title
coagulative variable
Description
coagulative change included antithrombin III activity (%).
Time Frame
baseline, 10 min after tourniquet release
Title
body temperature
Description
Tympanic temperature measurements were made using Braun Thermoscan inserted into the auditory canal
Time Frame
at 1 min just before the start of spinal anesthesia as a baseline and at 10 min after tourniquet release.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged between 20 and 80 years, American Society of Anesthesiologists (ASA) physical status class I-III, who were scheduled to undergo elective TKA Exclusion Criteria: 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
Facility Information:
Facility Name
WonwangUH
City
Iksan
State/Province
Jeonbuk
ZIP/Postal Code
570-711
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Dexmedetomidine on Tourniquet Induced -Systemic Effects

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