Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery
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|ClinicalTrials.gov Identifier: NCT03120234|
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid Free Anaesthesia||Drug: Dexmedetomidine Drug: Ketamine Drug: Fentanyl Drug: Placebos||Not Applicable|
Opioid Free Anesthesia (OFA) is a technique where no intraoperative opioid is administered during the anesthetic management. Opioid free anesthesia is usually achieved through sympatholysis, analgesia, and anesthesia with dexmedetomidine and analgesia with low dose ketamine. In addition paracetamol and other non-steroidal anti inflammatory drugs (NSAIDS) may be used as adjuncts to the multi-modal pain regimen.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery for Haemodynamic Stability and Recovery Characteristics|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||December 2017|
Experimental: 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.
Experimental: 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
o.9% normal saline will be used instead of ketamine
- To measure the emerence and extubation times in both groups [ Time Frame: 15minutes ]it is measured by noting the time for emergence and extubation after stopping inhalational anaesthesia.
- to measure the level of emergence in both the groups [ Time Frame: 15min ]using Riker sedation-agitation score
- to measure the level of cognition in both the groups [ Time Frame: 15min ]using Short orientation memory concentration test (SOMC test)
- comparison of intraoperative hemodynamic stability in both the groups [ Time Frame: intra operative period ]this will be done by monitoring intraoperative hemodynamics and noting down no of events of hypotension and hypertension and noting down the rescue drug requirements.
- postoperative pain assessment by using numeric rating scale [ Time Frame: 24 hrs ]
- comparing postoperative analgesic dose requirement in both the groups [ Time Frame: 24hrs ]
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): NCT03120234
|Post graduation institute of medical education and research|
|Chandigarh, India, 160012|
|Principal Investigator:||AYYAWAR HAREESH, MBBS||Post Graduate Institute of Medical Education and Research|