Skip to main content
OpenTrials
Completed

NCT Number: NCT03120234

Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Post graduation institute of medical education and research

Chandigarh, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

ketamine

Drug

Fentanyl

Drug

Placebos

Drug

o.9% normal saline will be used instead of ketamine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery for Haemodynamic Stability and Recovery Characteristics

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2017
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.