Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03120234
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ayyawar Hareesh, Postgraduate Institute of Medical Education and 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.

Condition or disease Intervention/treatment Phase
Opioid Free Anaesthesia Drug: Dexmedetomidine Drug: Ketamine Drug: Fentanyl Drug: Placebos Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery for Haemodynamic Stability and Recovery Characteristics
Actual Study Start Date : January 2017
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. to measure the level of emergence in both the groups [ Time Frame: 15min ]
    using Riker sedation-agitation score

  3. to measure the level of cognition in both the groups [ Time Frame: 15min ]
    using Short orientation memory concentration test (SOMC test)


Secondary Outcome Measures :
  1. 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.

  2. postoperative pain assessment by using numeric rating scale [ Time Frame: 24 hrs ]
  3. comparing postoperative analgesic dose requirement in both the groups [ Time Frame: 24hrs ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120234


Locations
Layout table for location information
India
Post graduation institute of medical education and research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Layout table for investigator information
Principal Investigator: AYYAWAR HAREESH, MBBS Post Graduate Institute of Medical Education and Research
Layout table for additonal information
Responsible Party: Ayyawar Hareesh, principal investigator, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03120234    
Other Study ID Numbers: MK/2950/MD/13121
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Fentanyl
Dexmedetomidine
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia