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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Free Anaesthesia
• Intervention / Treatment: Drug: Fentanyl; Drug: Dexmedetomidine; Drug: Ketamine; Drug: Placebos

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Post graduation institute of medical education and research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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	Drug: Fentanyl; Drug: Placebos; o.9% normal saline will be used instead of ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the emerence and extubation times in both groups	it is measured by noting the time for emergence and extubation after stopping inhalational anaesthesia.	15minutes
to measure the level of emergence in both the groups	using Riker sedation-agitation score	15min
to measure the level of cognition in both the groups	using Short orientation memory concentration test (SOMC test)	15min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of intraoperative hemodynamic stability in both the groups	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.	intra operative period
postoperative pain assessment by using numeric rating scale		24 hrs
comparing postoperative analgesic dose requirement in both the groups		24hrs

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): October 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (ACTUAL): April 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Ketamine; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: MK/2950/MD/13121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED