EpilepsyNCT02988050
Conscious Sedation for Epilepsy Surgery
A study testing Remifentanil, Dexmedetomidine and Propofol in people with Epilepsy, run by Menoufia University.
Trial summary
Sixty patients were randomly allocated into two groups, group PD and group PR, thirty patients in each group. Patients in PD group received propofol and dexmedetomidine intravenous infusion and patients in PR group received propofol and remifentanil intravenous infusion. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Remifentanil, Dexmedetomidine and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients require conscious sedation for epilepsy surgery
Who cannot join
- Patients refusal, allergy to drugs used, and uncooperative patients.
About this study
Official title: Propofol-dexmedetomidine Versus Propofol-remifentanil Conscious Sedation for Awake Craniotomy During Epilepsy Surgery
Sixty patients were randomly allocated into two groups, group PD and group PR, thirty patients in each group. Patients in PD group received propofol and dexmedetomidine intravenous infusion and patients in PR group received propofol and remifentanil intravenous infusion. Sedation score and patients' satisfaction, surgeon satisfaction, heart rate, mean arterial blood pressure, oxygen saturation, and side effects such as respiratory depression, nausea, vomiting, airway obstruction, and oxygen desaturation were recorded.
Read the detailed description
After approval from the ethics committee of Menoufia University Hospitals and informed written consent, the present study was conducted on sixty patients of both sexes. Patients' age was between 18-50 years, American society of anesthesiologists (ASA) I and II and scheduled for awake craniotomy for treatment of epilepsy. Exclusion criteria included patients with history of allergy to any of the drugs used for the study, patients with alcohol or substance abuse, pregnant females, patients with mental instability, morbid obese patients, and patients with liver, kidney, or cardiac comorbidities.
Patients were randomly allocated using computerized software into two groups, thirty patients in each group to receive intra-operative either propofol-dexmedetomidine (PD group) or propofol-remifentanil (PR group) intravenous infusion. All patients received their routine treatment for epilepsy at their scheduled time before surgery. All patients were fully monitored intra-operatively for heart rate, non-invasive blood pressure, oxygen saturation, respiratory rate, and bi-spectral index (BIS). Oxygen was supplied to all patients via nasal cannula peri-operatively.
Anaesthesia was achieved by regional scalp block and IV sedation. Regional blockade of the scalp was performed using bupivacaine 0.5% and 2% lidocaine with epinephrine 1/200.000. The branches of the cranial nerves blocked were supratrochlear, supraorbital, auriculotemporal, greater and lesser occipital, great auricular, zygomatic, and infraorbital nerves. Supplemental local anesthetic solution was used to infiltrate along the incision lines prior to skin incision. During craniotomy, a mixture of 0.25% bupivacaine and lidocaine1% without epinephrine was used to anesthetize the dura mater. The maximum dose of lidocaine used did not exceed 4.5 mg kg -1 and for bupivacaine 3 mg kg -1.
All patients received propofol 1% with a starting intravenous infusion dose of 250 μg kg-1 min-1 for 15 min and then basal infusion dose at 50 μg kg-1min-1. Sedation was achieved for group PD by a combination of propofol and dexmedetomidine with a starting infusion dose of 1ug kg-1 hr -1 for 15 min, and then titrated down to 0.2μ g kg-1 hr-1.
In PR group, IV sedation was achieved by a combination of propofol and remifentanil at an initial bolus dose of 0.5 μg.kg-1 over 60 seconds and then a basal infusion of 0.1μg kg-1 min1. Insufficient sedation in both groups was treated with boluses of 250 μg kg-1 propofol. The total amount of propofol used in both groups was recorded.
Sedation was assessed using Ramsay sedation score.6 Patient scored (1) if was anxious, agitated, or restless. Patient scored (2) if was cooperative, oriented and tranquil. Score 3 was for patients responded to command only. Score (4) for patients exhibited brisk respond to light glabellar tap or loud auditory stimulus. Score (5) for patients exhibited a sluggish response to light glabellar tap or loud auditory stimulus. Score (6) was for patients exhibited no response. Score (1) means inadequate sedation, score (2 to 4) means acceptable sedation, and score (5) or (6) means excessive sedation. Bi-spectral index (BIS) was connected to all patients and recorded every half an hour intra-operatively until the end surgery.
For intraoperative neurophysiologic monitoring propofol infusion was stopped for 15 minutes to avoid interference.
Side effects such as respiratory depression (respiratory rate less than 8/min), nausea, vomiting, airway obstruction, oxygen desaturation (oxygen saturation less than 90 %), and hypotension or hypertension (20% decrease or increase from the base line) were recorded. In case of apnea, respiratory depression, oxygen desaturation, and airway obstruction or hypotension all infusions were stopped until normalization and then the infusion resumed at half the basal rate. Vomiting was treated with 4mg intravenous ondansetron and the total ondansetron consumption was recorded for both groups.
If intraoperative convulsions occurred at any time IV thiopental sodium was given at a dose 1-2 mg kg-1. General anaesthesia was given if indicated and the patient was removed from the study. The excluded patients were replaced according to the schedule of randomization to keep the number of the two groups. Indications for general anesthesia were failure of the regional block, marked patient irritability, severe airway obstruction required intubation, uncontrolled convulsions, and haemodynamic instability.
Patient's satisfaction was recorded using a score ranging from 0 not satisfied and 10 totally satisfied. Surgeon satisfaction regarding the operative conditions and the anesthetic technique was recorded as 0 very bad operative conditions, 1 moderate, and 2 good.
Statistical analysis Sample size calculation was calculated using graphed instant statistics version 3. Based on previous research, dexmedetomidine was expected to produce a decrease in the heart rate by about 10 beats /minute with a standard deviation of 10 and by choosing 5% level of significance and power of 90% the calculated sample size was 22 so that, the sample size used in the study was 30 patients to ensure reliable results.
Data were analyzed using SPSS 19 program. Student t-test was used for comparing data between the two groups. Chi square test was used to compare the incidence of side effects. P value of less than 0.05 was considered to be statistically significant.
- Conditions
- Epilepsy
- Being tested
- Remifentanil, Dexmedetomidine, Propofol, Bupivacaine, Lidocaine
- Keywords
- Epilepsy Surgery, Conscious sedation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Remifentanil used for conscious sedation.
DexmedetomidineDrug
Dexmedetomidine used for conscious sedation.
PropofolDrug
Used for conscious sedation.
BupivacaineDrug
Local anaesthetics
LidocaineDrug
Local anaesthetic
EpinephrineDrug
With local anaesthetic for skin infiltration.
| Study group | Role | What they receive |
|---|---|---|
| Propofol-dexmedetomidine | Other | Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration) Receives: Drug: Dexmedetomidine; Drug: Propofol; Drug: Bupivacaine; Drug: Lidocaine; Drug: Epinephrine |
| Propofol-remifentanil | Other | Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration) Receives: Drug: Remifentanil; Drug: Propofol; Drug: Bupivacaine; Drug: Lidocaine; Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Satisfaction
Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.
Measured: 1 hour after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startAug 2013
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ezzeldin Ibrahim, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988050
- Sponsor's protocol ID
- MenoufiaU2016
- Status last verified
- Sep 2020
- First submitted
- 28 Nov 2016
- Last updated
- 9 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol-dexmedetomidine Versus Propofol-remifentanil Conscious Sedation for Awake Craniotomy During Epilepsy Surgery
- ClinicalTrials.gov ID
- NCT02988050
- Acronym / sponsor ID
- MenoufiaU2016
- Conditions
- Epilepsy
- Keywords
- Epilepsy Surgery, Conscious sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Posted 9 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sixty patients were randomly allocated into two groups, group PD and group PR, thirty patients in each group. Patients in PD group received propofol and dexmedetomidine intravenous infusion and patients in PR group received propofol and remifentanil intravenous infusion. Sedation score and patients' satisfaction, surgeon satisfaction, heart rate, mean arterial blood pressure, oxygen saturation, and side effects such as respiratory depression, nausea, vomiting, airway obstruction, and oxygen desaturation were recorded.
Detailed description
After approval from the ethics committee of Menoufia University Hospitals and informed written consent, the present study was conducted on sixty patients of both sexes. Patients' age was between 18-50 years, American society of anesthesiologists (ASA) I and II and scheduled for awake craniotomy for treatment of epilepsy. Exclusion criteria included patients with history of allergy to any of the drugs used for the study, patients with alcohol or substance abuse, pregnant females, patients with mental instability, morbid obese patients, and patients with liver, kidney, or cardiac comorbidities.
Patients were randomly allocated using computerized software into two groups, thirty patients in each group to receive intra-operative either propofol-dexmedetomidine (PD group) or propofol-remifentanil (PR group) intravenous infusion. All patients received their routine treatment for epilepsy at their scheduled time before surgery. All patients were fully monitored intra-operatively for heart rate, non-invasive blood pressure, oxygen saturation, respiratory rate, and bi-spectral index (BIS). Oxygen was supplied to all patients via nasal cannula peri-operatively.
Anaesthesia was achieved by regional scalp block and IV sedation. Regional blockade of the scalp was performed using bupivacaine 0.5% and 2% lidocaine with epinephrine 1/200.000. The branches of the cranial nerves blocked were supratrochlear, supraorbital, auriculotemporal, greater and lesser occipital, great auricular, zygomatic, and infraorbital nerves. Supplemental local anesthetic solution was used to infiltrate along the incision lines prior to skin incision. During craniotomy, a mixture of 0.25% bupivacaine and lidocaine1% without epinephrine was used to anesthetize the dura mater. The maximum dose of lidocaine used did not exceed 4.5 mg kg -1 and for bupivacaine 3 mg kg -1.
All patients received propofol 1% with a starting intravenous infusion dose of 250 μg kg-1 min-1 for 15 min and then basal infusion dose at 50 μg kg-1min-1. Sedation was achieved for group PD by a combination of propofol and dexmedetomidine with a starting infusion dose of 1ug kg-1 hr -1 for 15 min, and then titrated down to 0.2μ g kg-1 hr-1.
In PR group, IV sedation was achieved by a combination of propofol and remifentanil at an initial bolus dose of 0.5 μg.kg-1 over 60 seconds and then a basal infusion of 0.1μg kg-1 min1. Insufficient sedation in both groups was treated with boluses of 250 μg kg-1 propofol. The total amount of propofol used in both groups was recorded.
Sedation was assessed using Ramsay sedation score.6 Patient scored (1) if was anxious, agitated, or restless. Patient scored (2) if was cooperative, oriented and tranquil. Score 3 was for patients responded to command only. Score (4) for patients exhibited brisk respond to light glabellar tap or loud auditory stimulus. Score (5) for patients exhibited a sluggish response to light glabellar tap or loud auditory stimulus. Score (6) was for patients exhibited no response. Score (1) means inadequate sedation, score (2 to 4) means acceptable sedation, and score (5) or (6) means excessive sedation. Bi-spectral index (BIS) was connected to all patients and recorded every half an hour intra-operatively until the end surgery.
For intraoperative neurophysiologic monitoring propofol infusion was stopped for 15 minutes to avoid interference.
Side effects such as respiratory depression (respiratory rate less than 8/min), nausea, vomiting, airway obstruction, oxygen desaturation (oxygen saturation less than 90 %), and hypotension or hypertension (20% decrease or increase from the base line) were recorded. In case of apnea, respiratory depression, oxygen desaturation, and airway obstruction or hypotension all infusions were stopped until normalization and then the infusion resumed at half the basal rate. Vomiting was treated with 4mg intravenous ondansetron and the total ondansetron consumption was recorded for both groups.
If intraoperative convulsions occurred at any time IV thiopental sodium was given at a dose 1-2 mg kg-1. General anaesthesia was given if indicated and the patient was removed from the study. The excluded patients were replaced according to the schedule of randomization to keep the number of the two groups. Indications for general anesthesia were failure of the regional block, marked patient irritability, severe airway obstruction required intubation, uncontrolled convulsions, and haemodynamic instability.
Patient's satisfaction was recorded using a score ranging from 0 not satisfied and 10 totally satisfied. Surgeon satisfaction regarding the operative conditions and the anesthetic technique was recorded as 0 very bad operative conditions, 1 moderate, and 2 good.
Statistical analysis Sample size calculation was calculated using graphed instant statistics version 3. Based on previous research, dexmedetomidine was expected to produce a decrease in the heart rate by about 10 beats /minute with a standard deviation of 10 and by choosing 5% level of significance and power of 90% the calculated sample size was 22 so that, the sample size used in the study was 30 patients to ensure reliable results.
Data were analyzed using SPSS 19 program. Student t-test was used for comparing data between the two groups. Chi square test was used to compare the incidence of side effects. P value of less than 0.05 was considered to be statistically significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol-dexmedetomidine | Other | Drug: Dexmedetomidine, Drug: Propofol, Drug: Bupivacaine, Drug: Lidocaine, Drug: EpinephrinePropofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration) |
| Propofol-remifentanil | Other | Drug: Remifentanil, Drug: Propofol, Drug: Bupivacaine, Drug: Lidocaine, Drug: EpinephrinePropofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients require conscious sedation for epilepsy surgery
Key exclusion criteria (1 listed)
- Patients refusal, allergy to drugs used, and uncooperative patients.
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 |
|---|---|---|
| RemifentanilRemifentanil used for conscious sedation. | Drug | Propofol-remifentanil |
| DexmedetomidineDexmedetomidine used for conscious sedation. | Drug | Propofol-dexmedetomidine |
| PropofolUsed for conscious sedation. | Drug | Propofol-dexmedetomidine, Propofol-remifentanil |
| BupivacaineLocal anaesthetics | Drug | Propofol-dexmedetomidine, Propofol-remifentanil |
| LidocaineLocal anaesthetic | Drug | Propofol-dexmedetomidine, Propofol-remifentanil |
| EpinephrineWith local anaesthetic for skin infiltration. | Drug | Propofol-dexmedetomidine, Propofol-remifentanil |
Primary outcome
Patients Satisfaction
Time frame: 1 hour after the operation
Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil, Dexmedetomidine and Propofol in people with Epilepsy, run by Menoufia University.
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 1 inclusion and 1 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 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patients Satisfaction (time frame: 1 hour after the operation). 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 9 Oct 2020.