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Low Dose Perioperative Ketamine Infusion and it's Effect on Postoperative Pain Score, Sedation Score and Narcotic Consumption in Patients Undergoing Spine Surgery: A Prospective Randomized Double Blind Control Trial.

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ClinicalTrials.gov Identifier: NCT04259476
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
dr. sana siddiq, Services Institute of Medical Sciences, Pakistan

Brief Summary:
Low dose perioperative ketamine infusion and it's effect on postoperative pain score, sedation score and narcotic consumption in patients undergoing spine surgery: A prospective randomized double blind control trial.

Condition or disease Intervention/treatment Phase
for Post-operative Pain Relief in Spine Surgeries Drug: Ketamine Hydrochloride Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized control trial
Masking: Single (Investigator)
Masking Description: double blind
Primary Purpose: Supportive Care
Official Title: Low Dose Perioperative Ketamine Infusion and it's Effect on Postoperative Pain Score, Sedation Score and Narcotic Consumption in Patients Undergoing Spine Surgery: A Prospective Randomized Double Blind Control Trial.
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group A
WIll be given low dose perioperative ketamine infusion, as well as a ketamine bolus at start of surgery.
Drug: Ketamine Hydrochloride
low dose perioperative ketamine infusion. and its effects on post-operative pain.
Other Name: placebo, normal saline intrathecally.

Placebo Comparator: group B
will be given normal saline infusion and bolus at start of surgery.
Drug: Ketamine Hydrochloride
low dose perioperative ketamine infusion. and its effects on post-operative pain.
Other Name: placebo, normal saline intrathecally.




Primary Outcome Measures :
  1. post operative pain score [ Time Frame: upto 24 hours ]
    visual analogue scoring will be done for 24 hours post-operatively



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- A total of 60 adult patients aged between 18 and 60 years old with American Society of Anesthesiology (ASA) physical status I-II scheduled for elective spine surgery

Exclusion Criteria:

  • BMI more than 40 kg/m2
  • poorly controlled arterial hypertension (blood pressure higher than 140/90 mmHg)
  • respiratory, liver or kidney disease
  • heart disease (heart block or myocardial ischemia)

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): NCT04259476


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       nailaakhtar@gmail.com   
Sponsors and Collaborators
Services Institute of Medical Sciences, Pakistan
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Responsible Party: dr. sana siddiq, assistant professor, Services Institute of Medical Sciences, Pakistan
ClinicalTrials.gov Identifier: NCT04259476    
Other Study ID Numbers: servicesanesthesia
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
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:
post-operative analgesia, ketamine, multi-modal therapy
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action