Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

Ketamine

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.

Intervention / Treatment

  • Dexmedetomidine (DRUG)
    N/A
  • Ketamine (DRUG)
    N/A
  • Fentanyl (DRUG)
    N/A
  • Placebos (DRUG)
    o.9% normal saline will be used instead of ketamine

Condition or Disease

  • Opioid Free Anaesthesia

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 60 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Health Services Research

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jan 01, 2017 ACTUAL
    Primary Completion: Oct 01, 2017 ACTUAL
    Completion Date: Dec 01, 2017 ACTUAL
    Study First Posted: Apr 19, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 04, 2019

    Sponsors / Collaborators

    Lead Sponsor: Postgraduate Institute of Medical Education and Research
    Responsible Party: N/A

    Location

    Chandigarh, India

    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.

    Participant Groups

    • 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.

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    • it is measured by noting the time for emergence and extubation after stopping inhalational anaesthesia.

    • using Riker sedation-agitation score

    • using Short orientation memory concentration test (SOMC test)

    Secondary Outcomes

    • 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 24 hrs
    • comparing postoperative analgesic dose requirement in both the groups 24hrs

    More Details

    NCT Number: NCT03120234
    Other IDs: MK/2950/MD/13121
    Study URL: https://clinicaltrials.gov/study/NCT03120234
    Last updated: Sep 29, 2023