Comparison of Different Doses of Dexmedetomidine Effect in the Duration of Spinal Anesthesia

Small doses of dexmedetomidine1.5,3, 5µg used in combination with bupivacaine, in humans for spinal anesthesia has been shown to produce a more rapid onset of motor block, and a longer duration of motor and sensory block with preserved hemodynamic stability and lack of sedation.

Study Overview

• Status: Unknown
• Conditions: Spinal Anesthesia Duration
• Intervention / Treatment: Drug: intrathecal Dexmedetomidine; Drug: Dexmedetomidine 1.5 micrograms; Drug: Dexmedetomidine 3 micrograms; Drug: Dexmedetomidine 5 micrograms

Detailed Description

Spinal anesthesia has many advantages such as reducing the metabolic stress response to surgery, reduction in blood loss, decrease in the incidence of venous thromboembolism, reduction in pulmonary compromise (particularly in patients with advanced pulmonary disease),return of bowel function rapidly, allow hospital discharge early and the ability to monitor the patient's mental status, but the limited duration of action is one of its disadvantages. Intrathecal α2-agonists prolong the duration of action of local anesthetics and reduce the total required dose.(1, 2) Dexmedetomidine is a centrally acting highly specific α2 -agonist and its α2/α1 selectivity are 8 times higher than that of clonidine.(3) It is commonly used as a sedative, preemptive analgesic,(4) to decrease the incidence of postoperative nausea, vomiting (PONV)(5) and to maintain stable hemodynamics(6). It also has been used as an additive to local anesthetics in peripheral nerve blocks, brachial plexus block7, subarachnoid anesthesia and caudal anesthesia (8).

Local anesthetics have been widely used in medical practice to produce anesthesia, analgesia and for pain management. Nowadays, minor surgical operations have been done under local anesthesia outside the operating theaters, in this area monitoring and resuscitation facilities of the case are suboptimal compared to operating rooms. The complications of local anesthesia are different from localized reactions such as urticaria, edema, and dermatitis to systemic absorption leading to severe cardiovascular collapse and neurological toxicity. The incidence of local anesthetics to produce systemic toxicity decreased in the past 30 years, from 0.2 to 0.01 %.( 9) Recently, patient safety changes a clinician's perspective on understanding the pharmacology of drug interactions and complications of local anesthetics. The safety of local anesthetic usage has improved owing to the introduction of newer agents (eg; Ropivacaine and Levobupivacaine). (10) Levobupivacaine is a long-acting local anesthetic similar to that of Bupivacaine in a pharmacological structure. Bupivacaine, a widely used local anesthetic in regional anesthesia presents in a commercial preparation as a racemic mixture (50:50) of its two enantiomers, Levobupivacaine, S (-) isomer and destroy- bupivacaine, R (+) isomer.

Levobupivacaine has been shown to have a safer pharmacological profile (11) with less cardiac and neurotoxic adverse effects. (12) Small doses of dexmedetomidine 5µg used in combination with Levobupivacaine, in humans for spinal anesthesia has been shown to produce a more rapid onset of motor block, and a longer duration of motor and sensory block with preserved hemodynamic stability and lack of sedation2.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 1234
      • Recruiting
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients' physical status by the American Association of Anesthesiology (ASA): ASA I, II, III, undergoing Lower abdominal surgeries of maximum duration 2hrs

Exclusion Criteria:

• patients who refuse regional anesthesia or patient with bleeding tendency, taking α2- adrenergic agonist, labile hypertension, uncontrolled cardiac disease, heart block/dysrhythmia, difficulty in communication e.g. mental retardation or deafness, body weight more than 120kg or height less than 150cm, allergic to any of the drugs used in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; intrathecal Dexmedetomidine received 3mL (15mg) of 0.5% levobupivacaine +0.5mL normal saline .	Drug: intrathecal Dexmedetomidine; injection of different doses of Dexmedetomidine intrathecally received 3mL (15mg) of 0.5% levobupivacaine +0.5mL normal saline.; Other Names: saline intrathecally
Experimental: 1.5 DEX; Dexmedetomidine 1.5 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (1.5μg) dexmedetomidine	Drug: Dexmedetomidine 1.5 micrograms; injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 1.5 micrograms of Dexmedetomidine.; Other Names: Dexmedetomidine 1.5 micrograms intrathecally
Experimental: 3 DEX; Dexmedetomidine 3 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (3μg) dexmedetomidine	Drug: Dexmedetomidine 3 micrograms; injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 3 micrograms of Dexmedetomidine.; Other Names: Dexmedetomidine 3 micrograms intrathecally
Experimental: 5 DEX; Dexmedetomidine 5 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (5μg) dexmedetomidine	Drug: Dexmedetomidine 5 micrograms; injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 5 micrograms of Dexmedetomidine.; Other Names: Dexmedetomidine 5 micrograms intrathecally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of sensory block	time from onset of spinal to full recovery	6 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2017
• Primary Completion (Anticipated): July 30, 2017
• Study Completion (Anticipated): July 30, 2017

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 7, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: Dexmedetomidine12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No