Dexmetomidine Intrathecally and Intravenously Additionally to Spinal Anaesthesia, in Total Knee Arthroplasty

NCT02966249 | Unknown Phase 4

• 1 other identifier: 9092
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is designed to evaluate and compare the efficacy of intrathecal dexmedetomidine (DEX) as an adjuvant to Levobupivacaine in spinal anaesthesia and DEX's intravenous administration, without loading dose, additionally to spinal anaesthesia, in patients undergoing total knee arthroplasty.

Conditions

Neuromuscular Block

Keywords

dexmetomidine, intrathecally, intavenously,anesthesia

Outcome Measures

Primary Outcomes (3)

• Onset and duration of sensory block using the ' pin-prick ' method,in total knee athroplasty, using DEX as an adjuvant to intrathecal Levobuvicaine and iv administration additionally to spinal anesthesia with Levobuvicaine

  By using a hypodermic needle at 2 min interval, we will assess the 'pin-prick' sensation from T12 to S1 The onset of sensory block will be tested by 'pin-prick method' using a hypodermic needle at 2 minutes interval. The time of onset will be taken from the time of injection of drug into subarachnoid space to loss of pinprick sensation to T12 level. We study 90 patients(ASAI-II) devided in 3 groups and we measure the highest level of sensory block, time for two dermatomal segments regression of sensory level, duration of sensory blockade taken as time from onset to time of return of pinprick sensation to S1 (heel) dermatomal area will be noted.

  The time of onset will be taken from the time of injection of drug intrathecally to loss of pinprick sensation to T12 within 30 min. Duration of sensory blockade will be measured as time from onset to time of return of piniprick sensation to S1 level.

• Onset and duration of motor block using the Modified Bromage Scale, in total knee athroplasty, using DEX as an adjuvant to intrathecal Levobuvicaine and iv administration additionally to spinal anesthesia with Levobuvicaine

  By using the Modified Bromage Scale we will assess the onset and duration of motor block. Grade 0 : Full flexion of knees and feet. Grade 1: Just able to flex knees, full flexion of feet. Grade 2: Unable to flex knees, but some flexion of feet possible. Grade 3; Unable to move legs or feet.

  Onset time will be taken from the time of injection of drug intrathecally to the patient's inability to lift the extended leg within 30 min. The duration will be taken from time of injection of drug to the patient's ability to lift the extended leg.

• Duration of post-operative analgesia using the Visual Analogue Scale (VAS), in total knee arthroplasty, using DEX as an adjuvant to intrathecal Levobuvicaine and iv administration additionally to spinal anesthesia with Levobuvicaine

  VAS is a scale from 0 to 10, with 0 indicating 'no pain' and 10 indicating the most severe pain, that somebody has experienced. Rescue analgesics will be given to the patients when VAS\>3, which will be the cut-off point of our study.

  We will record the post-operative analgesia using the Visual Analogue Scale (VAS) at the end of the surgery and 3, 6, 12,24 hours after the end of the surgeryn and at the end of the surgery. an interval of 3, 6 ,and 12 h after surgery

Secondary Outcomes (5)

• Hemodynamic stability of DEX, used as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anesthesia, in total knee arthroplasy

  SAP will be recorded at the time of the spinal injection, 10, 20, 30,45, 60 min after spinal injection and at the end of the surgery.

• Hemodynamic stability of DEX, used as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anesthesia, in total knee arthroplasy

  DAP will be recorded will be recorded at the time of the spinal injection, 10, 20, 30,45, 60 min after spinal injection and at the end of the surgery.

• Hemodynamic stability of DEX, used as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anesthesia, in total knee arthroplasy

  HR will be recorded will be recorded at the time of the spinal injection, 10, 20, 30,45, 60 min after spinal injection and at the end of the surgery.

• Adverse effects of DEX, used as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anaesthesia with Levobupivacaine, in total knee arthroplasy

  Adverse effects will be recorded will be recorded at the time of the spinal injection, 15, 30, 60 min after spinal injection, at the end of the surgery and 3, 6, 12, 24 hours after the end of the surgery

• Sedation will be assessed with the Ramsay Sedation Scale, in total knee arthroplasty, by using DEX as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anesthesia with Levobuvicaine

  Sedation scores will be assessed will be recorded at the time of the spinal injection, 10, 20, 30,45, 60 min after spinal injection, at the end of the surgery and 30 minutes after the end of the surgery

Study Arms (6)

Levobupivacaine intrathecally

OTHER

3 ml Levobupivacaine 0,5% (15mg) given intrathecally once for anesthesia in total knee arthroplasty

Drug: Levobupivacaine; Drug: Normal Saline intrathecally

Dexmetomidine intrathecally

ACTIVE COMPARATOR

5 μgr Dexmetomidine given intrathecally once for anesthesia in total knee arthroplasty

Drug: Levobupivacaine; Drug: Normal Saline added intrathecally; Drug: Dexmetomidine intrathecally

Dexmetomidine intravenously

ACTIVE COMPARATOR

Continuous infusion of dexdemetomidine at a rate of 0.25 μg/kg/h given intravenously starting 10 min before spinal anesthesia in total knee arthroplasty

Drug: Levobupivacaine; Drug: Dexmetomidine intravenously; Drug: Ringer's Lactate solution intravenously

Normal Saline intrathecally

PLACEBO COMPARATOR

0,5 ml Normal Saline given intrathecally given once for spinal anesthesia in total knee arthroplasty

Drug: Levobupivacaine; Drug: Normal Saline added intrathecally; Drug: Dexmetomidine intrathecally

Normal Saline added intrathecally

OTHER

Normal Saline added intrathecally up to 0,5 ml given intrathecally for spinal anesthesia in total knee arthroplasty

Drug: Levobupivacaine; Drug: Normal Saline intrathecally; Drug: Dexmetomidine intrathecally

Ringer's Lactate solution intravenously

OTHER

Continuous infusion of Ringer's Lactate solution given intravenously for total knee arthroplasty will start 10 minutes before spinal anesthesia to the end of the operation

Drug: Levobupivacaine; Drug: Dexmetomidine intravenously; Drug: Ringer's Lactate solution intravenously

Interventions

Levobupivacaine DRUG

3 ml Levobupivacaine 0.5% (15mg) given intrathecally

Also known as: LB

Dexmetomidine intrathecally; Dexmetomidine intravenously; Levobupivacaine intrathecally; Normal Saline added intrathecally; Normal Saline intrathecally; Ringer's Lactate solution intravenously

Dexmetomidine intravenously DRUG

Continuous infusion of dexdemetomidine at a rate of 0.25 μg/kg/h given intravenously 10 min before spinal anesthesia in total knee arthroplasty

Also known as: DEX

Dexmetomidine intravenously; Ringer's Lactate solution intravenously

Normal Saline added intrathecally DRUG

Normal Saline added to 5μgr dexmetomidine up to 0,5 ml given intrathecally for spinal anesthesia in total knee arthroplasty

Also known as: N/S

Dexmetomidine intrathecally; Normal Saline intrathecally

Normal Saline intrathecally DRUG

0,5 ml Normal Saline given intrathecally given once for spinal anesthesia in total knee arthroplasty

Also known as: N/S

Levobupivacaine intrathecally; Normal Saline added intrathecally

Ringer's Lactate solution intravenously DRUG

Continuous infusion of Ringer's Lactate solution given intravenously, starting 10 minutes before spinal anesthesia up to the end of the operation

Also known as: R/L

Dexmetomidine intravenously; Ringer's Lactate solution intravenously

Dexmetomidine intrathecally DRUG

5 μgr dexmetomidine given intrathecally once for anesthesia in total knee replacement

Also known as: DEX

Dexmetomidine intrathecally; Normal Saline added intrathecally; Normal Saline intrathecally

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients selected for total knee arthroplasty of approximately one and half hour (90 min) duration under spinal anaesthesia.
• Patients who belong to American Society of Anaesthesiologists (ASA) physical status grade I and II

You may not qualify if:

• Patients allergic to DEX
• Patients showing unwillingness for spinal anaesthesia

Sponsors & Collaborators

• KAT General Hospital: lead

Study Sites (1)

Kat General Hospital of Attca

Kifissia, 14561, Greece

RECRUITING

Related Publications (2)

• Zhang H, Li M, Zhang SY, Fu M, Zhang SY. Intravenous Dexmedetomidine Promotes Spinal Bupivacaine Anesthesia and Postoperative Analgesia in Lower Limb Surgery: A Double-Blind, Randomized Clinical CONSORT Study. Medicine (Baltimore). 2016 Feb;95(8):e2880. doi: 10.1097/MD.0000000000002880.

  PMID: 26937924 BACKGROUND

• Chan IA, Maslany JG, Gorman KJ, O'Brien JM, McKay WP. Dexmedetomidine during total knee arthroplasty performed under spinal anesthesia decreases opioid use: a randomized-controlled trial. Can J Anaesth. 2016 May;63(5):569-76. doi: 10.1007/s12630-016-0597-y. Epub 2016 Jan 29.

  PMID: 26830642 BACKGROUND

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Efi Stavropoulou

  KAT GENERAL HOSPITAL OF ATTICA

  STUDY CHAIR

• Cathrin Chazapis

  KAT General Hospital of Athens

  STUDY CHAIR

Central Study Contacts

Marianthi Konstantinidou

CONTACT

+306973028610; anaisthdocs1-kat@0306.syzefxis.gov.gr

Ioanna Diagoupi

CONTACT

00306976564296; diag-anna@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intern doctor in anaesthesiology

Study Record Dates

• First Submitted: August 28, 2016
• First Posted: November 17, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 17, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)