Spinal Anesthesia Clinical Trial
Official title:
The Impact of Dexmedetomidine on Tourniquet Induced -Systemic Effects in Total Knee Arthroplasty Under Spinal Anesthesia-prospective Study.
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.
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02565303 -
Minimum Effective Dose of Ropivacaine for Spinal Anesthesia for Cesarean Delivery
|
N/A | |
Recruiting |
NCT03248817 -
Phenylephrine Infusion in Cesarean Delivery
|
Phase 4 | |
Completed |
NCT02840006 -
Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass
|
Phase 4 | |
Completed |
NCT01624844 -
Predictive Value of Ultrasound Measurement of the Dural Sac Volume on the Sensory Level in Spinal Anesthesia
|
N/A | |
Recruiting |
NCT00974961 -
Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia
|
Phase 4 | |
Recruiting |
NCT00492453 -
Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
|
N/A | |
Completed |
NCT05549011 -
PENG vs SIFI Block for Positioning Pain During Spinal Anesthesia
|
||
Completed |
NCT03805503 -
Chloroprocaine for Inguinal Herniorrhaphy
|
Phase 4 | |
Completed |
NCT03775655 -
Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section
|
Phase 2/Phase 3 | |
Completed |
NCT03199170 -
Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section
|
N/A | |
Completed |
NCT03302039 -
Three Protocols for Phenylephrine Administration in Cesarean Delivery
|
Phase 4 | |
Not yet recruiting |
NCT05063292 -
Effect of Prewarming On Skin Temperature Changes
|
N/A | |
Not yet recruiting |
NCT05583214 -
Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia
|
Phase 4 | |
Recruiting |
NCT02937792 -
Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section
|
N/A | |
Recruiting |
NCT01415284 -
ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
|
Phase 4 | |
Completed |
NCT00537472 -
Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time
|
N/A | |
Completed |
NCT05548985 -
Midodrine for Prophylaxis Against Post Spinal Hypotension in Elderly Population
|
N/A | |
Completed |
NCT03322098 -
Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia
|
N/A | |
Recruiting |
NCT04598061 -
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
|
||
Completed |
NCT04083768 -
Effect of Different Left Lateral Table Tilt for Elective Cesarean Delivery Under Spinal Anesthesia
|
N/A |