Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

Opioid Free Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120234
• Other study ID #: MK/2950/MD/13121
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: July 2019
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Free Anaesthesia

Intervention

Drug:
• Dexmedetomidine

• Ketamine

• Fentanyl

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

Locations

Country	Name	City	State
India	Post graduation institute of medical education and research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	to measure the level of emergence in both the groups	using Riker sedation-agitation score	15min
Primary	to measure the level of cognition in both the groups	using Short orientation memory concentration test (SOMC test)	15min
Secondary	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
Secondary	postoperative pain assessment by using numeric rating scale		24 hrs
Secondary	comparing postoperative analgesic dose requirement in both the groups		24hrs