Clinical trial NCT03120234: Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery
Official title: Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery for Haemodynamic Stability and Recovery Characteristics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Free Anaesthesia
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* patients suffering significant pituitary adenocarcinomas posted for transsphenoidal resection of tumor
* age group between 18 to 65 yr
* Both males and females
* ASA physical status 1 to 2

Exclusion Criteria:

* pts taking opioid for chronic pain
* 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

Primary outcomes:
measure: To measure the emerence and extubation times in both groups
timeFrame: 15minutes
measure: to measure the level of emergence in both the groups
timeFrame: 15min
measure: to measure the level of cognition in both the groups
timeFrame: 15min
Secondary outcomes:
measure: comparison of intraoperative hemodynamic stability in both the groups
timeFrame: intra operative period
measure: postoperative pain assessment by using numeric rating scale
timeFrame: 24 hrs
measure: comparing postoperative analgesic dose requirement in both the groups
timeFrame: 24hrs
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post graduation institute of medical education and research
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: AYYAWAR HAREESH, MBBS
role: PRINCIPAL_INVESTIGATOR
References: