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

NCT03143010 | Unknown

• 1 other identifier: Dexmedetomidine12
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Anesthesia Duration

Outcome Measures

Primary Outcomes (1)

• duration of sensory block

  time from onset of spinal to full recovery

  6 hours

Study Arms (4)

control group

PLACEBO COMPARATOR

intrathecal Dexmedetomidine received 3mL (15mg) of 0.5% levobupivacaine +0.5mL normal saline .

Drug: intrathecal Dexmedetomidine

1.5 DEX

EXPERIMENTAL

Dexmedetomidine 1.5 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (1.5μg) dexmedetomidine

Drug: Dexmedetomidine 1.5 micrograms

3 DEX

EXPERIMENTAL

Dexmedetomidine 3 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (3μg) dexmedetomidine

Drug: Dexmedetomidine 3 micrograms

5 DEX

EXPERIMENTAL

Dexmedetomidine 5 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (5μg) dexmedetomidine

Drug: Dexmedetomidine 5 micrograms

Interventions

intrathecal Dexmedetomidine DRUG

injection of different doses of Dexmedetomidine intrathecally received 3mL (15mg) of 0.5% levobupivacaine +0.5mL normal saline.

Also known as: saline intrathecally

control group

Dexmedetomidine 1.5 micrograms DRUG

injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 1.5 micrograms of Dexmedetomidine.

Also known as: Dexmedetomidine 1.5 micrograms intrathecally

1.5 DEX

Dexmedetomidine 3 micrograms DRUG

injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 3 micrograms of Dexmedetomidine.

Also known as: Dexmedetomidine 3 micrograms intrathecally

3 DEX

Dexmedetomidine 5 micrograms DRUG

injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 5 micrograms of Dexmedetomidine.

Also known as: Dexmedetomidine 5 micrograms intrathecally

5 DEX

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 1234, Egypt

RECRUITING

Central Study Contacts

Hassan Ali, lecturer

CONTACT

1001733687; hassan364@hotmail.com

Bassant Hassan, lecturer

CONTACT

+201001733687; hassan364@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: May 7, 2017
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

EG (1)