Opioid Free AnaesthesiaNCT03120234
Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery
A study testing Dexmedetomidine, Ketamine and Fentanyl in people with Opioid Free Anaesthesia, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Free Anaesthesia
- What is being tested?
- Dexmedetomidine, Ketamine and Fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Post graduation institute of medical education and research
Chandigarh, 160012
About this study
Official title: Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery for Haemodynamic Stability and Recovery Characteristics
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.
Read the 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.
- Conditions
- Opioid Free Anaesthesia
- Being tested
- Dexmedetomidine, Ketamine, Fentanyl, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
KetamineDrug
FentanylDrug
PlacebosDrug
o.9% normal saline will be used instead of ketamine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Fentanyl; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15minutes
to measure the level of emergence in both the groups
using Riker sedation-agitation score
Measured: 15min
to measure the level of cognition in both the groups
using Short orientation memory concentration test (SOMC test)
Measured: 15min
Secondary outcomes (3)
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.
Measured: intra operative period
postoperative pain assessment by using numeric rating scale
Measured: 24 hrs
comparing postoperative analgesic dose requirement in both the groups
Measured: 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startJan 2017
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Free AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayyawar Hareesh, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- AYYAWAR HAREESH, MBBS, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120234
- Sponsor's protocol ID
- MK/2950/MD/13121
- Status last verified
- Jul 2019
- First submitted
- 6 Jan 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery for Haemodynamic Stability and Recovery Characteristics
- ClinicalTrials.gov ID
- NCT03120234
- Acronym / sponsor ID
- MK/2950/MD/13121
- Conditions
- Opioid Free Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine and ketamine | Experimental | Drug: Dexmedetomidine, Drug: KetamineThe 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. |
| fentanyl and placebo | Experimental | Drug: Fentanyl, Drug: Placebospts 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- pts taking opioid for chronic pain
- Pregnant or nursing woman
- Preoperative GCS <15
- HR<50/min
- Patients with allergies to study medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine and ketamine |
| Ketamine | Drug | Dexmedetomidine and ketamine |
| Fentanyl | Drug | fentanyl and placebo |
| Placeboso.9% normal saline will be used instead of ketamine | Drug | fentanyl and placebo |
Primary outcome
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)
3 secondary outcomes
comparison of intraoperative hemodynamic stability in both the groups
Time frame: intra operative period
postoperative pain assessment by using numeric rating scale
Time frame: 24 hrs
comparing postoperative analgesic dose requirement in both the groups
Time frame: 24hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYYAWAR HAREESH, MBBS principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Ketamine and Fentanyl in people with Opioid Free Anaesthesia, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the emerence and extubation times in both groups (time frame: 15minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.