search
Back to results

Conscious Sedation for Epilepsy Surgery

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remifentanil
Dexmedetomidine
Propofol
Bupivacaine
Lidocaine
Epinephrine
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy focused on measuring Epilepsy Surgery, Conscious sedation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients require conscious sedation for epilepsy surgery

Exclusion Criteria:

  • Patients refusal, allergy to drugs used, and uncooperative patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Propofol-dexmedetomidine

    Propofol-remifentanil

    Arm Description

    Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)

    Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)

    Outcomes

    Primary Outcome Measures

    Patients Satisfaction
    Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 28, 2016
    Last Updated
    September 16, 2020
    Sponsor
    Menoufia University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02988050
    Brief Title
    Conscious Sedation for Epilepsy Surgery
    Official Title
    Propofol-dexmedetomidine Versus Propofol-remifentanil Conscious Sedation for Awake Craniotomy During Epilepsy Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Menoufia University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy
    Keywords
    Epilepsy Surgery, Conscious sedation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Propofol-dexmedetomidine
    Arm Type
    Other
    Arm Description
    Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)
    Arm Title
    Propofol-remifentanil
    Arm Type
    Other
    Arm Description
    Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Intervention Description
    Remifentanil used for conscious sedation.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Intervention Description
    Dexmedetomidine used for conscious sedation.
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Intervention Description
    Used for conscious sedation.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Intervention Description
    Local anaesthetics
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Intervention Description
    Local anaesthetic
    Intervention Type
    Drug
    Intervention Name(s)
    Epinephrine
    Intervention Description
    With local anaesthetic for skin infiltration.
    Primary Outcome Measure Information:
    Title
    Patients Satisfaction
    Description
    Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.
    Time Frame
    1 hour after the operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients require conscious sedation for epilepsy surgery Exclusion Criteria: Patients refusal, allergy to drugs used, and uncooperative patients.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Conscious Sedation for Epilepsy Surgery

    We'll reach out to this number within 24 hrs