Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery
NCT ID: NCT03120234
Last Updated: 2019-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-01-31
2017-12-31
Brief Summary
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Detailed Description
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Dexmedetomidine, a highly selective agonist of the alpha2 adrenergic receptor, has many clinical benefits, such as sedation, analgesia, preventing unwanted stress responses and low risk of respiratory depression. Because of concern that opioids might cause perioperative respiratory depression, substitution with dexmedetomidine will be helpful with its analgesic and sympatholytic properties. Dexmedetomidine has shown to reduce minimum alveolar concentration (MAC) of inhalational anesthetics and the requirement of perioperative opioid by 30-50%. In neurosurgical patients, dexmedetomidine is helpful in maintaining intracranial pressure (ICP) and intraoperative hemodynamic stability, especially during intubation and extubation. It can allow for faster awakening and thus an earlier neurological examination by decreasing necessary volatile agent and opioid doses.
Ketamine, an N-methyl-d-aspartate(NMDA) antagonist, blunts central pain sensitization at sub-anesthetic doses (0.5 mg/kg or less) and has been studied extensively as an adjunct for perioperative analgesia. Sub-anesthetic ketamine improves pain scores and reduces perioperative opioid consumption in a broad range of surgical procedures.Recent literature has suggested that adjuvant ketamine administration in mechanically ventilated patients has no cerebrovascular effects.
The present study has been planned to compare the effect of opioid free anesthesia using dexmedetomidine and ketamine with opioid based anesthesia using fentanyl in maintaining the intraoperative hemodynamic stability and recovery characteristics in patients undergoing TSS of pituitary tumors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Dexmedetomidine and ketamine
The group will receive loading dose of dexmedetomidine 1mcg/kg over 10 Min followed by a maintenance of 0.5 mcg/ kg/ hr.ketamine 0.5 mg/kg will be given as bolus at the time of induction.
Dexmedetomidine
Ketamine
fentanyl and placebo
pts will receive fentanyl 2mcg/kg as bolus over 10 Mon followed by 1 mcg/ kg/hr as maintenance, instead of ketamine placebo(0.9%saline ) will be given in control group
Fentanyl
Placebos
o.9% normal saline will be used instead of ketamine
Interventions
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Dexmedetomidine
Ketamine
Fentanyl
Placebos
o.9% normal saline will be used instead of ketamine
Eligibility Criteria
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Inclusion Criteria
* age group between 18 to 65 yr
* Both males and females
* ASA physical status 1 to 2
Exclusion Criteria
* Pregnant or nursing woman
* Preoperative GCS \<15
* HR\<50/min
* Patients with allergies to study medication
* Patients with psychiatric disorder
* Patients with unstable cardiorespiratory disorder
* Patients with hepatic and renal insufficiency
18 Years
65 Years
ALL
Yes
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Ayyawar Hareesh
principal investigator
Principal Investigators
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AYYAWAR HAREESH, MBBS
Role: PRINCIPAL_INVESTIGATOR
Post Graduate Institute of Medical Education and Research, Chandigarh
Locations
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Post graduation institute of medical education and research
Chandigarh, , India
Countries
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Other Identifiers
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MK/2950/MD/13121
Identifier Type: -
Identifier Source: org_study_id
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