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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04037774
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
dr. sana siddiq, Services Institute of Medical Sciences, Pakistan

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.

Condition or disease Intervention/treatment Phase
Drug Effect Drug: Dexmedetomidine Other: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized control design
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Comparision of Different Doses of Dexmedetomidine With Low Dose Bupivacaine in Selective Spinal Anesthesia for Transurethral Resection of Prostate in Elderly Males.
Estimated Study Start Date : September 2, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: dex 5microgram
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
comparision of different doses of dexmedetomidine used intrathecally

Active Comparator: dex 10microgram
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
comparision of different doses of dexmedetomidine used intrathecally

Placebo Comparator: placebo
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
addition of placebo with local anesthetic to create a control group




Primary Outcome Measures :
  1. duration of post-operative analgesia [ Time Frame: upto 6months ]
    duration the patient remains pain free from administration of drug.


Secondary Outcome Measures :
  1. peak sensory level [ Time Frame: upto 6 months ]
    peak sensory level attained after drug administration

  2. 2 segment regression [ Time Frame: upto 6 months ]
    time to achieve 2 segment regression from the time at which patient achieved peak sensory level

  3. side effects [ Time Frame: upto 6 months ]
    side effects noted during and after surgery



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only in transuretheral resection of prostate patients.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037774


Contacts
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Contact: sana siddiq, FCPS 00923343368803 dr.sana.wasiq@hotmail.com
Contact: naila asad, fcps

Locations
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Pakistan
Services Institute of Medical Sciences Recruiting
Lahore, Punjab, Pakistan, 042
Contact: sana siddiq, fcps    00923343368803    dr.sana.wasiq@hotmail.com   
Contact: naila asad, fcps         
Sponsors and Collaborators
Services Institute of Medical Sciences, Pakistan
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Responsible Party: dr. sana siddiq, professor of anesthesiology, Services Institute of Medical Sciences, Pakistan
ClinicalTrials.gov Identifier: NCT04037774    
Other Study ID Numbers: simsanesthesia
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by dr. sana siddiq, Services Institute of Medical Sciences, Pakistan:
analgesia,
spinal block
dexmedetomidine
bupivacaine
selective spinal anesthesia
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action