The Prolonging Effect of Dexmedetomidine on Spinal Anesthesia Through Different Routes if Administrations

NCT06769737 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: ICTR24/001/11
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, double-blinded, randomized clinical trial aims to examine the effects of combining isobaric bupivacaine with dexmedetomidine administered intrathecally (IT), compared to the combination of isobaric bupivacaine administered intrathecally and dexmedetomidine administered intravenously (IV), on spinal anesthesia prolongation time in minutes, time of regression from Bromage score 3 to 0.

Conditions

Spinal Anesthesia Evaluation

Keywords

dexmedetomedine; intrathecal dexmedetomedine; intravenous dexmedetomedine; spinal anesthesia prolongation

Outcome Measures

Primary Outcomes (1)

• Regression time of Bromage score from 3 to 0

  This double-blind study will include 75 participants divided equally into three groups: A, B, and C. The IT medication injection / IV infusion start time is considered time zero. The Bromage score will be assessed at the motor block's onset, representing a Bromage score of 3, recorded in minutes. The record of the time to reach Bromage 3 represents the spinal anesthesia's onset time. The Bromage scale is a clinical scale used to determine motor block during regional anesthesia. It evaluates lower limb movement, grade 0, no motor block, to grade 3, complete motor block. Bromage 0; the patient can move hip, knee, and ankle. No motor block Bromage 1: the patient cannot move the hip but can move the knee and ankle. Partial block Bromage 2: the patient cannot move the hip and knee but can move the ankle. partial block Bromage 3: the patient cannot move the hip, knee, and ankle. Complete motor block A Bronage score regression to 0 during a PACU stay will represent a spinal anesthesia offset

  Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.

Secondary Outcomes (2)

• Hypotension, bradycardia and desaturation with dermatome coverage <T4 or >T4, checked by Ice test.

  Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.

• Sedation score using Ramsay sedation score, aiming for score 2; calm and oriented.

  Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.

Study Arms (3)

Controlled

NO INTERVENTION

Group A: Control group. Receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + 0.15 ml of normal saline (placebo), total volume = 2.4 ml. Through IV, 15 ml of normal saline ( placebo) will be received over 30 mins.

Dexmedetomidine HCL IT

EXPERIMENTAL

Group B: RECEIVING IT "Dexmedetomidine HCL," "Demexa®," Through IT, receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) +3mcg of "Dexmedetomidine HCL, (0.15 ml), total volume = 2.4 ml. Through IV, 15 ml of normal saline ( placebo) will be received over 30 mins.

Drug: Interventional group#1

Dexmedetomidine HCL IV

EXPERIMENTAL

Group C: RECEIVING IV "Dexmedetomidine HCL," "Demexa®," Through IT, receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + Placebo of normal saline (0.15 ml), total volume = 2.4 ml. Through IV, 0.5 mcg/kg of "Dexmedetomidine HCL" is prepared in a concentration of 2 mcg/ml ( maximum of 15 ml, 30 mcg) over 30 mins.

Drug: Interventional group#2

Interventions

Interventional group#1 DRUG

The intrathecal mixture of spinal anesthesia: 12 mg of isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + 20 mcg of "Fentanyl," "Martindale pharma Fentanyl®," 50mcg/ml (0.4ml) + 3 mcg of "Dexmedetomidine HCL," "Demexa®," 4mcg/ml (0.75 ml) total volume = 3.55 ml. The Bromage score will be assessed by the anesthesiologist every 5 minutes after positioning the patient supine until the first incision. The Bromage score is a clinical scale used to determine motor block during regional anesthesia by evaluating lower limb movement: Grade 0: Full movement of hips, knees, and ankles (no block). Grade 1: Unable to lift the leg but can move knees and ankles (partial block). Grade 2: Unable to bend the knee but can move ankles (near-complete block). Grade 3: No movement in hips, knees, or ankles (complete block). Dermatomal coverage will be assessed simultaneously till it reaches the L1-L2 level. Also, The Ramsay Sedation Scale (RSS) will be used to evaluate the sedation depth, if any.

Also known as: Intrathecal "Dexmedetomidine HCL," "Demexa®,"

Dexmedetomidine HCL IT

Interventional group#2 DRUG

The intrathecal mixture of spinal anesthesia: 12 mg of isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + 20 mcg of "Fentanyl," "Martindale pharma Fentanyl®," 50mcg/ml (0.4ml) total volume = 2.8 ml. The intravascular mixture consists of 0.5 mcg/kg of "Dexmedetomidine HCL," "Demexa®," and a maximum of 30 mcg diluted to 4 mcg/ml. According to body weight, the total volume is 7.5 ml or less and given using a syringe pump over 30 minutes. The anesthesiologist will start the infusion once the patient is positioned supine post-spinal anesthesia and has stable hemodynamics. The Bromage score will be assessed by the anesthesiologist every 5 minutes after positioning the patient supine until the first incision reaches grade 3: No movement in hips, knees, or ankles (complete block). The anesthesiologist will assess dermatomal coverage until it reaches the L1-L2 and calculate the Ramsay Sedation Scale (RSS) of the depth of sedation aiming for level 2: Patient is cooperative, oriented, and calm

Also known as: Intravascular "Dexmedetomidine HCL," "Demexa®,"

Dexmedetomidine HCL IV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients in adult age group more than 18 years old
• ASA classification I, II, and III.
• Orthopedic surgery, including total hip replacement (THR) and total knee replacement (TKR).
• No history of Obstructive sleep apnea

You may not qualify if:

• Patient below 18 years old of both genders.
• ASA classification of IV and more.
• Patients with a height of less than 150 cm.
• Patients on alpha-two antagonist ACE inhibitors and CCB.
• Patient received intrathecal morphine, intravascular dexamethasone, or Midazolam
• Patient who can't tolerate fluid challenge. Example: ESRD, HF…etc.
• Any contraindication for neuraxial procedure. Examples: coagulopathy, severe AS, sepsis…etc.
• Psychiatric patients.

Sponsors & Collaborators

• King Abdulaziz Medical City: lead

Study Sites (1)

King Abdulaziz Medical City

Riyadh, 11551, Saudi Arabia

Location

Related Publications (10)

• Abdallah FW, Abrishami A, Brull R. The facilitatory effects of intravenous dexmedetomidine on the duration of spinal anesthesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jul;117(1):271-8. doi: 10.1213/ANE.0b013e318290c566. Epub 2013 Apr 30.

  PMID: 23632057 BACKGROUND

• Kaya FN, Yavascaoglu B, Turker G, Yildirim A, Gurbet A, Mogol EB, Ozcan B. Intravenous dexmedetomidine, but not midazolam, prolongs bupivacaine spinal anesthesia. Can J Anaesth. 2010 Jan;57(1):39-45. doi: 10.1007/s12630-009-9231-6. Epub 2009 Dec 29.

  PMID: 20039221 BACKGROUND

• Al-Mustafa MM, Abu-Halaweh SA, Aloweidi AS, Murshidi MM, Ammari BA, Awwad ZM, Al-Edwan GM, Ramsay MA. Effect of dexmedetomidine added to spinal bupivacaine for urological procedures. Saudi Med J. 2009 Mar;30(3):365-70.

  PMID: 19271064 BACKGROUND

• Kanazi GE, Aouad MT, Jabbour-Khoury SI, Al Jazzar MD, Alameddine MM, Al-Yaman R, Bulbul M, Baraka AS. Effect of low-dose dexmedetomidine or clonidine on the characteristics of bupivacaine spinal block. Acta Anaesthesiol Scand. 2006 Feb;50(2):222-7. doi: 10.1111/j.1399-6576.2006.00919.x.

  PMID: 16430546 BACKGROUND

• Lundblad M, Trifa M, Kaabachi O, Ben Khalifa S, Fekih Hassen A, Engelhardt T, Eksborg S, Lonnqvist PA. Alpha-2 adrenoceptor agonists as adjuncts to peripheral nerve blocks in children: a meta-analysis. Paediatr Anaesth. 2016 Mar;26(3):232-8. doi: 10.1111/pan.12825. Epub 2015 Dec 16.

  PMID: 26671834 BACKGROUND

• Visavakul O, Leurcharusmee P, Pipanmekaporn T, Khorana J, Patumanond J, Phinyo P. Effective Dose Range of Intrathecal Isobaric Bupivacaine to Achieve T5-T10 Sensory Block Heights for Elderly and Overweight Patients: An Observational Study. Medicina (Kaunas). 2023 Mar 1;59(3):484. doi: 10.3390/medicina59030484.

  PMID: 36984485 BACKGROUND

• Uppal V, Retter S, Shanthanna H, Prabhakar C, McKeen DM. Hyperbaric Versus Isobaric Bupivacaine for Spinal Anesthesia: Systematic Review and Meta-analysis for Adult Patients Undergoing Noncesarean Delivery Surgery. Anesth Analg. 2017 Nov;125(5):1627-1637. doi: 10.1213/ANE.0000000000002254.

  PMID: 28708665 BACKGROUND

• Taye MG, Molla A, Teshome D, Hunie M, Kibret S, Fentie Y, Temesgen N, Engidaw MT, Fenta E. Predictors of hypoxemia after general anesthesia in the early postoperative period in a hospital in Ethiopia: an observational study. Multidiscip Respir Med. 2021 Dec 1;16(1):782. doi: 10.4081/mrm.2021.782. eCollection 2021 Jan 15.

  PMID: 35003732 BACKGROUND

• Bekker AY, Kaufman B, Samir H, Doyle W. The use of dexmedetomidine infusion for awake craniotomy. Anesth Analg. 2001 May;92(5):1251-3. doi: 10.1097/00000539-200105000-00031. No abstract available.

  PMID: 11323355 BACKGROUND

• Khan ZP, Ferguson CN, Jones RM. alpha-2 and imidazoline receptor agonists. Their pharmacology and therapeutic role. Anaesthesia. 1999 Feb;54(2):146-65. doi: 10.1046/j.1365-2044.1999.00659.x.

  PMID: 10215710 BACKGROUND

Central Study Contacts

Hebah Musalem, Anesthesia Asistant consultant

CONTACT

00966533112656; hebamusallam91@gmail.com

Mohammad Al Harbi, Anesthesia Consultant,

CONTACT

00966508818000; HarbiMK@mngha.med.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Assistant consultant

Model Details: This prospective, single-blinded, randomized clinical trial compares the effects of intrathecal (IT) dexmedetomidine combined with isobaric bupivacaine and intravenous (IV) dexmedetomidine combined with intrathecal isobaric bupivacaine on the duration of spinal anesthesia. The study includes one control group and two interventional groups.

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: January 10, 2025
• Study Start: March 1, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

SA (1)