Electroconvulsive TherapyNCT05408000
Comparision of Motor Seizure Duration of Ketofol and Propofol for Electroconvulsive Therapy
A study testing ketofol vs propofol in people with Electroconvulsive Therapy, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Electroconvulsive Therapy
- What is being tested?
- ketofol vs propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2021to 15 Jun 2021
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • 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
Show all 10Show fewer
- 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:
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and other psychiatric diseases. Currently, most ECT procedures are carried out with muscle paralysis under general anesthesia. It is important to establish an accurate balance between adequate anesthesia depth and optimal seizure duration. The objective of anesthesia during ECT is to provide a rapid onset and balance of both unconsciousness and muscle relaxation for the duration of the electrical stimulus and subsequent seizure .Therefore, anesthetics that are used for general anesthesia during ECT should have rapid onset, rapid emergence, no interference with seizure activity and
longer seizure duration. A motor seizure lasting 20-25 seconds at minimum has been typically recommended for therapeutic efficacy of ECT . Common drugs used for ECT anesthesia are methohexital, thiopental, etomidate, propofol and ketamine. Methohexital exerts depressant action on seizure activity and is contraindicated in patients acute intermittent porphyria. Etomidate causes increased incidence of emesis. Similarly incidence of sinus bradycardia and premature ventricular contraction increased with the use of thiopental during ECT procedures .
For these reasons methohexital, thiopental and etomidate are not used in current anesthetic practice for electroconvulsive therapy Propofol as an anaesthetic in ECT has favorable characteristics such as rapid onset and emergence from anesthesia, minimal postoperative confusion and a lower incidence of hypertension or tachycardia during induction of anesthesia. However, it produces a dose- dependent decrease in seizure duration . Ketamine, is also used as an anesthetic agent in ECT because it has a favorable seizure inducing effect and increased seizure duration. But it is also not devoid of disadvantages. Its main disadvantages are that it produces hypertension, delayed recovery and precipitates psychomimetic emergence phenomena . So ketofol (1:1combination of ketamine and propofol) can be a good alternative to either propofol or ketamine used alone for anesthetic management for ECT. Ketamine mitigates propofol-induced hypotension, and propofol mitigates ketamine-induced vomiting and emergence agitation. Ketofol can also have better outcome on motor seizure duration than propofol alone. Therefore, the present study is designed to test the hypothesis that ketofol would be a good alternative anesthetic agent and better than propofol for ECT procedures.After obtaining approval from Institutional Review committee (IRC) of TUTH and Nepal health research council (NHRC) the process of enrolling the eligible patients into the study will be started. Patients will be assessed for eligibility. Patients meeting the inclusion criteria and not having the exclusion criteria will be enrolled in the study. Patients will be divided into two groups: Group P (propofol group,n=27) and Group K (ketofol group ,n=27) using computer generated random numbers. Blinding will be done by sealed envelope technique. Pre-anesthetic checkup will be conducted and a detailed history and complete physical examination will be done prior to procedure. Informed consent will be taken from the legal guardian of patient. Patient will be transferred to the pre anesthetic room. Baseline hemodynamic parameters (SBP, DBP, MAP, SPO2 and HR) will be taken and recorded. An 18 G IV cannula will be secured in appropriate hand of patient. Patient will be premedicated with glycopyrolate 0.2 mg 30 minutes prior to procedure. Patient will be transferred to operation theatre. III ECG leads, SPO2 probe and NIBP pressure cuff will be attached. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and oxygen saturation (SPO2) will
be continually monitored. Preoxygenation will be done via facemask at the rate of 5liter/min for 5 minutes. Anesthesia assistant will pick an envelope for each patient. Test solution will be prepared by anesthesia assistant as per the instructions in the envelope. Group K - In 10 ml syringe, 2ml of ketamine (50mg/ml solution) and 8ml of normal saline will be drawn to make the 10mg/ml solution of ketamine. Finally in another new 10 ml syringe 5ml of the freshly prepared solution of ketamine (10mg/ml) and 5ml of propofol (10mg/ml) will be mixed. The study drug thus prepared will contain 5mg /ml of propofol and 5mg / ml of ketamine. There will be two such 10ml syringe of ketofol. Group P - propofol (10mg/ml solution) will be drawn in labeled 10ml syringe. Two such 10ml syringes of propofol will be prepared. Patient in Group K will be administered an initial dose of 0.5mg/kg ketofol (0.25 mg/kg of propofol + 0.25 mg/kg of ketamine). Similarly, patient in Group P will be given an initial dose of 0.5mg/kg propofol. In both the group this initial dose will be given within 15 seconds. Five seconds after administration of drug, patient will be assessed for unresponsiveness to verbal commands (by calling patient's name) \& loss of eyelash reflex. Then titrated dose of drug will be given at the rate of 1ml every 5 seconds until the patient no longer responds to verbal commands and there is loss of eyelash reflex. The required total dose of propofol or ketofol will be recorded. After loss of consciousness, hemodynamic parameters (SBP, DBP, MAP, HR \& SPO2) will be taken and recorded. An isolated forearm technique will be performed by inflating the tourniquet in arm where the iv cannula is not placed. Then, succinylcholine, 1 mg/kg iv will be administered. Ventilation will be assisted with 100 % oxygen via face mask in all groups during the procedure. Bite block will be used prior to application of bifrontal electrodes.
Then a psychiatrist blinded to the study groups will administer electrical stimuli through bifrontal electrodes. The frequency will be set at 90Hz and current will be set at 800 milliampere.
The duration of the motor seizure will be defined as the time from the ECT stimulus to cessation of tonic-clonic motor activity in the 'isolated' arm. After the end of seizure, bite block will be removed and ventilation will be continued with 100% oxygen via face mask. The duration of motor seizures will be recorded. Hemodynamic parameters (SBP, DBP, MAP and HR) will be recorded 1mins and 5 mins after the end of seizure. Common complication encountered during
ECT are transient hypertension and tachycardia. Esmolol 5mg iv bolus will be given during such episodes. The time from the end of succinylcholine administration until spontaneous breathing, eye opening, and obeying commands will be recorded. Once the patient is awake, obeys commands and maintains oxygen saturation without supplemental oxygen, the patient will be transferred to postoperative room. Patient will be monitored with ECG, pulse oximeter and noninvasive blood pressure for one hour in postoperative room and then the patient will be transferred.
- Conditions
- Electroconvulsive Therapy
- Being tested
- ketofol vs propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketofol vs propofolDrug
Also called ketofol and propofol
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
| Study group | Role | What they receive |
|---|---|---|
| ketofol | Active comparator | patient given titrated dose of ketofol Receives: Drug: ketofol vs propofol |
| propofol | Active comparator | patient given titrated dose of propofol Receives: Drug: ketofol vs propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor seizure duration
- To compare the duration of motor seizures between Ketofol and Propofol groups.
Measured: 20 to 25 seconds
Secondary outcomes (1)
• To compare the emergence time between the groups
eye opening, spontaneous breathing, obeys commands
Measured: 3 to 7 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jan 2021
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electroconvulsive TherapyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilip Baral, Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Investigators
- Dilip Baral, Md, Principal investigator, tuthrenu gurung, MD, Study chair, tuthhem raj paneru, MD, Study chair, tuthpankal joshi, MD, Study chair, tuth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408000
- Sponsor's protocol ID
- 1288
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of Motor Seizure Duration of Ketofol and Propofol for Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT05408000
- Acronym / sponsor ID
- 1288
- Conditions
- Electroconvulsive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 7 Jun 2022 (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.
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
Detailed description
Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and other psychiatric diseases. Currently, most ECT procedures are carried out with muscle paralysis under general anesthesia. It is important to establish an accurate balance between adequate anesthesia depth and optimal seizure duration. The objective of anesthesia during ECT is to provide a rapid onset and balance of both unconsciousness and muscle relaxation for the duration of the electrical stimulus and subsequent seizure .Therefore, anesthetics that are used for general anesthesia during ECT should have rapid onset, rapid emergence, no interference with seizure activity and
longer seizure duration. A motor seizure lasting 20-25 seconds at minimum has been typically recommended for therapeutic efficacy of ECT . Common drugs used for ECT anesthesia are methohexital, thiopental, etomidate, propofol and ketamine. Methohexital exerts depressant action on seizure activity and is contraindicated in patients acute intermittent porphyria. Etomidate causes increased incidence of emesis. Similarly incidence of sinus bradycardia and premature ventricular contraction increased with the use of thiopental during ECT procedures .
For these reasons methohexital, thiopental and etomidate are not used in current anesthetic practice for electroconvulsive therapy Propofol as an anaesthetic in ECT has favorable characteristics such as rapid onset and emergence from anesthesia, minimal postoperative confusion and a lower incidence of hypertension or tachycardia during induction of anesthesia. However, it produces a dose- dependent decrease in seizure duration . Ketamine, is also used as an anesthetic agent in ECT because it has a favorable seizure inducing effect and increased seizure duration. But it is also not devoid of disadvantages. Its main disadvantages are that it produces hypertension, delayed recovery and precipitates psychomimetic emergence phenomena . So ketofol (1:1combination of ketamine and propofol) can be a good alternative to either propofol or ketamine used alone for anesthetic management for ECT. Ketamine mitigates propofol-induced hypotension, and propofol mitigates ketamine-induced vomiting and emergence agitation. Ketofol can also have better outcome on motor seizure duration than propofol alone. Therefore, the present study is designed to test the hypothesis that ketofol would be a good alternative anesthetic agent and better than propofol for ECT procedures.After obtaining approval from Institutional Review committee (IRC) of TUTH and Nepal health research council (NHRC) the process of enrolling the eligible patients into the study will be started. Patients will be assessed for eligibility. Patients meeting the inclusion criteria and not having the exclusion criteria will be enrolled in the study. Patients will be divided into two groups: Group P (propofol group,n=27) and Group K (ketofol group ,n=27) using computer generated random numbers. Blinding will be done by sealed envelope technique. Pre-anesthetic checkup will be conducted and a detailed history and complete physical examination will be done prior to procedure. Informed consent will be taken from the legal guardian of patient. Patient will be transferred to the pre anesthetic room. Baseline hemodynamic parameters (SBP, DBP, MAP, SPO2 and HR) will be taken and recorded. An 18 G IV cannula will be secured in appropriate hand of patient. Patient will be premedicated with glycopyrolate 0.2 mg 30 minutes prior to procedure. Patient will be transferred to operation theatre. III ECG leads, SPO2 probe and NIBP pressure cuff will be attached. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and oxygen saturation (SPO2) will
be continually monitored. Preoxygenation will be done via facemask at the rate of 5liter/min for 5 minutes. Anesthesia assistant will pick an envelope for each patient. Test solution will be prepared by anesthesia assistant as per the instructions in the envelope. Group K - In 10 ml syringe, 2ml of ketamine (50mg/ml solution) and 8ml of normal saline will be drawn to make the 10mg/ml solution of ketamine. Finally in another new 10 ml syringe 5ml of the freshly prepared solution of ketamine (10mg/ml) and 5ml of propofol (10mg/ml) will be mixed. The study drug thus prepared will contain 5mg /ml of propofol and 5mg / ml of ketamine. There will be two such 10ml syringe of ketofol. Group P - propofol (10mg/ml solution) will be drawn in labeled 10ml syringe. Two such 10ml syringes of propofol will be prepared. Patient in Group K will be administered an initial dose of 0.5mg/kg ketofol (0.25 mg/kg of propofol + 0.25 mg/kg of ketamine). Similarly, patient in Group P will be given an initial dose of 0.5mg/kg propofol. In both the group this initial dose will be given within 15 seconds. Five seconds after administration of drug, patient will be assessed for unresponsiveness to verbal commands (by calling patient's name) \& loss of eyelash reflex. Then titrated dose of drug will be given at the rate of 1ml every 5 seconds until the patient no longer responds to verbal commands and there is loss of eyelash reflex. The required total dose of propofol or ketofol will be recorded. After loss of consciousness, hemodynamic parameters (SBP, DBP, MAP, HR \& SPO2) will be taken and recorded. An isolated forearm technique will be performed by inflating the tourniquet in arm where the iv cannula is not placed. Then, succinylcholine, 1 mg/kg iv will be administered. Ventilation will be assisted with 100 % oxygen via face mask in all groups during the procedure. Bite block will be used prior to application of bifrontal electrodes.
Then a psychiatrist blinded to the study groups will administer electrical stimuli through bifrontal electrodes. The frequency will be set at 90Hz and current will be set at 800 milliampere.
The duration of the motor seizure will be defined as the time from the ECT stimulus to cessation of tonic-clonic motor activity in the 'isolated' arm. After the end of seizure, bite block will be removed and ventilation will be continued with 100% oxygen via face mask. The duration of motor seizures will be recorded. Hemodynamic parameters (SBP, DBP, MAP and HR) will be recorded 1mins and 5 mins after the end of seizure. Common complication encountered during
ECT are transient hypertension and tachycardia. Esmolol 5mg iv bolus will be given during such episodes. The time from the end of succinylcholine administration until spontaneous breathing, eye opening, and obeying commands will be recorded. Once the patient is awake, obeys commands and maintains oxygen saturation without supplemental oxygen, the patient will be transferred to postoperative room. Patient will be monitored with ECG, pulse oximeter and noninvasive blood pressure for one hour in postoperative room and then the patient will be transferred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketofol | Active comparator | Drug: ketofol vs propofolpatient given titrated dose of ketofol |
| propofol | Active comparator | Drug: ketofol vs propofolpatient given titrated dose of propofol |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- • All patients scheduled for electroconvulsive therapy irrespective of ECT sessions.
- Exclus• Pregnant patients
- Patients with a history of Epilepsy
- Patients taking any anticonvulsant medication
- Patients with a history of substance abuse or dependence
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ketofol vs propofolAlso: ketofol and propofolPatients 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 | Drug | ketofol, propofol |
Primary outcome
Motor seizure duration
Time frame: 20 to 25 seconds
• To compare the duration of motor seizures between Ketofol and Propofol groups.
1 secondary outcome
• To compare the emergence time between the groups
Time frame: 3 to 7 minutes
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 7 Jun 2022.
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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.
Dilip Baral, Md principal investigator
tuth
renu gurung, MD study chair
tuth
hem raj paneru, MD study chair
tuth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketofol vs propofol in people with Electroconvulsive Therapy, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 10 inclusion and 0 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 7 Jun 2022. 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 Nepal. 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?
Motor seizure duration (time frame: 20 to 25 seconds). 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 7 Jun 2022.