Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

NCT03120234 | Completed

• 1 other identifier: MK/2950/MD/13121
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Free Anaesthesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• comparison of intraoperative hemodynamic stability in both the groups

  intra operative period

• postoperative pain assessment by using numeric rating scale

  24 hrs

• comparing postoperative analgesic dose requirement in both the groups

  24hrs

Study Arms (2)

Dexmedetomidine and ketamine

EXPERIMENTAL

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

fentanyl and placebo

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

Dexmedetomidine and ketamine

Ketamine DRUG

Dexmedetomidine and ketamine

Fentanyl DRUG

fentanyl and placebo

Placebos DRUG

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

fentanyl and placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post graduation institute of medical education and research

Chandigarh, 160012, India

Location

MeSH Terms

Interventions

Dexmedetomidine; Ketamine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines

Study Officials

• AYYAWAR HAREESH, MBBS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: April 19, 2017
• Study Start: January 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

IN (1)