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A clinical trial to compare the effect of two drugs - Dexmedetomidine and ketamine to decrease injection pain of propofol while giving general anaesthesia for non emergency surgeries.

Dexmedetomidine versus ketamine pretreatment to alleviate propofol injection pain in patients undergoing elective surgeries under general anaesthesia - a randomised and blinded study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/028996
Enrollment
140
Registered
2020-11-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R52- Pain, unspecified

Interventions

Intervention1: INJECTION DEXMEDETOMIDINE HYDROCHLORIDE: INJECTION DEXMEDETOMIDINE HYDROCHLORIDE 0.5mcg/kg INTRAVENOUS INFUSION SINGLE DOSE OVER 10 MINUTES PRIOR TO INJECTION PROPOFOL 2mg/kg AND SUBSEQ

Sponsors

Dr Prishel Mariam Prasad
Lead Sponsor
Dr Pranab Kalita
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.AMERICAN SOCIETY OF ANAESTHESIOLOGY(ASA) PHYSICAL STATUS 1 AND 2 2.SCHEDULED FOR ELECTIVE SURGERIES UNDER GENERAL ANAESTHESIA USING PROPOFOL AS THE INDUCTION AGENT.

Exclusion criteria

Exclusion criteria: 1.PATIENTS WITHOUT VALID CONSENT FOR THE STUDY 2.PATIENTS WITH SEVERE SYSTEMIC DISORDERS( RESPIRATORY, HEPATIC, RENAL, NEUROLOGICAL, PSYCHIATRIC, NEUROMUSCULAR, CARDIOVASCULAR DISORDERS SUCH AS PRE-EXISTING HEART BLOCK) 3.PATIENTS WITH KNOWN HYPERSENSITIVITY TO STUDY DRUGS 4.PREGNANT AND LACTATING PATIENTS 5.PATIENTS WITH MORBID OBESITY 6.PATIENTS SCHEDULED FOR EMERGENCY SURGERY 7.PATIENTS WITH DIFFICULTY IN COMMUNICATION.

Design outcomes

Primary

MeasureTime frame
1.TO COMPARE THE INCIDENCE OF PROPOFOL INJECTION PAIN AFTER DEXMEDETOMIDINE PRETREATMENT WITH THE INCIDENCE OF PROPOFOL INJECTION PAIN AFTER KETAMINE PRETREATMENT.Timepoint: FROM THE TIME OF STARTING INJECTION PROPOFOL, THE PATIENTS SHALL BE ASSESSED FOR PAIN EVERY 5 SECONDS UNTIL THE TIME THE PATIENT IS INDUCED WITH PROPOFOL

Secondary

MeasureTime frame
TO DESCRIBE THE HEMODYNAMIC SIDE EFFECTS THAT ARISE AFTER THE ADMINISTRATION OF THE PRETREATMENT DRUG(KETAMINE OR DEXMEDETOMIDINE)TILL THE TIME WHEN THE PATIENT HAS BEEN INDUCED WITH PROPOFOL.Timepoint: FROM THE TIME AFTER THE ADMINISTRATION OF THE PRETREATMENT DRUG(KETAMINE OR DEXMEDETOMIDINE)TILL THE TIME OF COMPLETION OF INDUCTION.

Countries

India

Contacts

Public ContactDr Pranab Kalita

Gauhati Medical College And Hospital Guwahati

11980pran@gmail.com7002181200

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026