Comparision of Motor Seizure Duration of Ketofol and Propofol for Electroconvulsive Therapy

NCT05408000 | Completed

• 1 other identifier: 1288
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Propofol is routinely used in our hospital for ECT. It causes hypotension and has anticonvulsant actions. Use of ketofol ( 1:1 combination of ketamine and propofol) during ECT can have longer seizure duration and better hemodynamics than propofol alone which ultimately leads to better therapeutic efficacy. Motor seizure duration of minimum 20-25 seconds is usually recommended for therapeutic efficacy of ECT.Patients planned for electroconvulsive therapy meeting the inclusion criteria and not having exclusion criteria will be randomized into two groups. Group K will receive titrated dose of Ketofol and Group P will receive titrated dose of Propofol for induction of anaesthesia

Conditions

Electroconvulsive Therapy

Outcome Measures

Primary Outcomes (1)

• Motor seizure duration

  • To compare the duration of motor seizures between Ketofol and Propofol groups.

  20 to 25 seconds

Secondary Outcomes (1)

• • To compare the emergence time between the groups

  3 to 7 minutes

Study Arms (2)

ketofol

ACTIVE COMPARATOR

patient given titrated dose of ketofol

Drug: ketofol vs propofol

propofol

ACTIVE COMPARATOR

patient given titrated dose of propofol

Drug: ketofol vs propofol

Interventions

ketofol vs propofol DRUG

Patients planned for electroconvulsive therapy meeting the inclusion criteria and not having exclusion criteria will be randomized into two groups. Group K will receive titrated dose of Ketofol and Group P will receive titrated dose of Propofol for induction of anaesthesia

Also known as: ketofol and propofol

ketofol; propofol

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients scheduled for electroconvulsive therapy irrespective of ECT sessions.
• Patients between 16 to 65 years of age
• Patients with ASA -PS of I and II
• Exclus• Pregnant patients
• Patients with a history of Epilepsy
• Patients taking any anticonvulsant medication
• Patients with a history of substance abuse or dependence
• Patients with a history of any adverse effect to any drugs used during the procedure
• ion Criteria:

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Study Sites (1)

Dr Dilip Baral

Kathmandu, Bagmati Province, Nepal

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Dilip Baral, Md

  tuth

  PRINCIPAL INVESTIGATOR

• renu gurung, MD

  tuth

  STUDY CHAIR

• hem raj paneru, MD

  tuth

  STUDY CHAIR

• pankal joshi, MD

  tuth

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant Anesthesiologist

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 7, 2022
• Study Start: January 1, 2021
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

NE (1)