Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

• ClinicalTrials.gov Identifier: NCT03120234
• Recruitment Status: Completed
• First Posted: April 19, 2017
• Last Update Posted: July 8, 2019
• Sponsor: Postgraduate Institute of Medical Education and Research
• Information provided by (Responsible Party): Ayyawar Hareesh, Postgraduate Institute of Medical Education and Research

Tracking Information

• First Submitted Date: January 6, 2017
• First Posted Date: April 19, 2017
• Last Update Posted Date: July 8, 2019
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2017)

• 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 17, 2017)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Health Services Research
• Condition: Opioid Free Anaesthesia

Intervention

• Drug: Dexmedetomidine
• Drug: Ketamine
• Drug: Fentanyl
• Drug: Placebos
  o.9% normal saline will be used instead of ketamine

Study Arms

• 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.
  Interventions:

  • Drug: Dexmedetomidine
  • Drug: Ketamine
• 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
  Interventions:

  • Drug: Fentanyl
  • Drug: Placebos

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2017): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT03120234
• Other Study ID Numbers: MK/2950/MD/13121
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Ayyawar Hareesh, Postgraduate Institute of Medical Education and Research
• Original Responsible Party: Same as current
• Current Study Sponsor: Postgraduate Institute of Medical Education and Research
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: AYYAWAR HAREESH, MBBS; Post Graduate Institute of Medical Education and Research

• PRS Account: Postgraduate Institute of Medical Education and Research
• Verification Date: July 2019