NCT03120234

Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery for Haemodynamic Stability and Recovery Characteristics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study has been planned to compare the effect of opioid free anaesthesia using dexmedetomidine and ketamine with opioid based anaesthesia using fentanyl in maintaining the intraoperative hemodynamic stability and recovery characteristics in patients undergoing Transsphenoidal surgery of pituitary tumors.

Detailed description

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.

Conditions

• Opioid Free Anaesthesia

Interventions

Type	Name	Description
DRUG	Dexmedetomidine
DRUG	Ketamine
DRUG	Fentanyl
DRUG	Placebos	o.9% normal saline will be used instead of ketamine

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2017-04-19
• Last updated: 2019-07-08

Locations

1 site across 1 country: India