Comparision of Different Doses of Dexmedetomidine With Low Dose Bupivacaine in Selective Spinal Anesthesia.

NCT04037774 | Unknown Phase 4

• 1 other identifier: simsanesthesia
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The charactereistics of a spinal block varies with the dose of local anaesthetic and the adjuvant used. Literature review did not show comparison of different doses of dexmedetomidine with low-dose bupivacaine in saddle block. The rationale of this study is to determine an optimum dose of dexmedetomidine which in combination with low dose bupivacaine would provide satisfactory block with hemodynamic stability. This would be beneficial for patients scheduled for turp, as these pts are mostly elderly with various comorbidities.

Conditions

Drug Effect

Keywords

analgesia,; spinal block; dexmedetomidine; bupivacaine; selective spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• duration of post-operative analgesia

  duration the patient remains pain free from administration of drug.

  upto 6months

Secondary Outcomes (3)

• peak sensory level

  upto 6 months

• 2 segment regression

  upto 6 months

• side effects

  upto 6 months

Study Arms (3)

dex 5microgram

ACTIVE COMPARATOR

this group of patients is given total 2ml solution intrathecally, 1ml of 5mg local anesthetic i.e 0.5% hyperbaric bupivacaine and 1ml of 5micrograms of dexmedetomidine.

Drug: Dexmedetomidine

dex 10microgram

ACTIVE COMPARATOR

this group of patients is given total 2ml solution intrathecally, 1ml of 5mg local anesthetic i.e 0.5% hyperbaric bupivacaine and 1ml of 10micrograms of dexmedetomidine.

Drug: Dexmedetomidine

placebo

PLACEBO COMPARATOR

this group of patients is given total 2ml solution intrathecally, 1ml of 5mg local anesthetic i.e 0.5% hyperbaric bupivacaine and 1ml of placebo.

Other: placebo

Interventions

Dexmedetomidine DRUG

comparision of different doses of dexmedetomidine used intrathecally

dex 10microgram; dex 5microgram

placebo OTHER

addition of placebo with local anesthetic to create a control group

placebo

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: only in transuretheral resection of prostate patients.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male gender Age between 50 and 70 years old Patients' physical status by the American Society of Anesthesiologist (ASA): ASA class I, II and III

You may not qualify if:

• Contraindications of spinal anesthesia, Patients who were taking α2-adrenergic agonist or antagonist therapy, Patients who were having labile hypertension, uncontrolled cardiac disease, heart block/dysrhythmia, autoimmune disorders, Communication difficulties, e.g. mental retardation or deafness Allergy to the drug or local anesthetics.

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 042, Pakistan

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

sana siddiq, FCPS

CONTACT

00923343368803; dr.sana.wasiq@hotmail.com

naila asad, fcps

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of anesthesiology

Model Details: randomized control design

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: July 30, 2019
• Study Start: September 2, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)