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Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

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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

Tracking Information
First Submitted Date  ICMJE January 6, 2017
First Posted Date  ICMJE April 19, 2017
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE Opioid Free Anaesthesia
Intervention  ICMJE
  • Drug: Dexmedetomidine
  • Drug: Ketamine
  • Drug: Fentanyl
  • Drug: Placebos
    o.9% normal saline will be used instead of ketamine
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03120234
Other Study ID Numbers  ICMJE MK/2950/MD/13121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ayyawar Hareesh, Postgraduate Institute of Medical Education and Research
Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP