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This will be a randomized blinded clinical trial. Patients will be randomized to receive either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia team will know the result of randomization at induction. Data will be gathered by research personnel who will be blinded to the anesthetic method used. Patients will be blinded to the anesthetic they receive till they are discharged from the PACU when they will have the option to be unblinded. The Data Safety and -Toxicity Committee will review all serious adverse events and toxicity reports as well as annual reviews.
Anesthesia for craniotomy presents a unique challenge to the anesthesiologist. Anesthesia for neurosurgical procedures should provide optimal surgical conditions while maintaining appropriate cerebral oxygen supply and stable systemic hemodynamics. (1) It is important to prevent patient response to noxious stimuli during the procedure like pinning, drilling of the bone, opening and manipulation of the dura etc., avoid coughing and bucking during surgery and during extubation thus necessitating a deeper level of anesthesia and analgesia. At the same time it is desirable to have the patient fully awake toward the end of the surgery in order to facilitate neurologic evaluation. Management of the above presents a challenge during induction, maintenance and extubation and also during multiple critical stages of surgery Fear of the side effects of analgesic drugs frequently leads to the under-treatment of post-craniotomy pain. (2) Nevertheless, this pain continues to be commonly observed, is frequently severe, and, if unrelieved, may cause distress for the neurosurgical patient and serious complications for the operative brain. (2) There is a need for larger trials to delineate safety and efficacy of analgesic therapies with a focus on short- and long-term outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil | Active Comparator | Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS |
|
| Dexmedetomidine | Active Comparator | a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamics | Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points. | 15, 30, 45, 60, and 90 minutes after extubation. |
| Postoperative Pain | Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points. | 15, 30, 45, 60, and 90 minutes after extubation. |
| Total Opioid Consumption | Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents. | Initial 90 minutes of recover after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach. | 15, 30, 45, 60, and 90 minutes after extubation. |
| Modified Short Orientation Memory Concentration Test (SOMCT) |
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Inclusion Criteria:
Patients who undergo general anesthesia for elective surgical excision of a brain tumor with following specifications:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shobana Rajan, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States | ||
| The Cleveland Clinic Foundation |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remifentanil | Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS |
| FG001 | Dexmedetomidine | a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Remifentanil | Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS |
| BG001 | Dexmedetomidine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemodynamics | Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points. | Posted | Mean | Standard Deviation | mmHg | 15, 30, 45, 60, and 90 minutes after extubation. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remifentanil | Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sessler, MD | Cleveland Clinic | 216-445-6500 | sesslerd@ccf.org |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Dexmedetomidine | Drug | a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. |
|
|
The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores > 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach. |
| 15, 30, 45, 60, and 90 minutes after extubation. |
| Aldrete Score | The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach. | 15, 30, 45, 60, and 90 minutes after extubation. |
| Nursing Workload Comparison | To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient). | 90 minutes after extubation |
| Drug Stop Time to Open Eyes | time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery | Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes. |
| Drug Stop Time to Recall | Time between extubation until patients could say their names. | Time between extubation until patients could say their names. |
| Drug Stop Time to Fitness to Discharge | Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes. |
| End Case to Post Anesthesia Care Unit (PACU) Discharge | Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge. | End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes. |
| Postoperative Nausea | Indicator of whether patients had nausea or not | Whether patients had nausea or not, from anesthesia stop time until hospital discharge. |
| Postoperative Vomitting | Indicator of whether patients had postoperative vomiting. | Whether patients had vomiting or not, from anesthesia stop time until hospital discharge. |
| Postoperative Shivering | Indicator of whether patients had postoperative shivering. | Whether patients had postoperative or not, from anesthesia stop time until hospital discharge. |
| Cleveland |
| Ohio |
| 44195 |
| United States |
a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
|
|
|
| Primary | Postoperative Pain | Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points. | Posted | Mean | Standard Deviation | units on a scale | 15, 30, 45, 60, and 90 minutes after extubation. |
|
|
|
|
| Primary | Total Opioid Consumption | Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents. | Posted | Median | Inter-Quartile Range | mg morphine equivalents | Initial 90 minutes of recover after surgery |
|
|
|
|
| Secondary | Heart Rate | Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach. | Posted | Mean | Standard Deviation | beats per minute | 15, 30, 45, 60, and 90 minutes after extubation. |
|
|
|
|
| Secondary | Modified Short Orientation Memory Concentration Test (SOMCT) | The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores > 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach. | Posted | Mean | Standard Deviation | units on a scale | 15, 30, 45, 60, and 90 minutes after extubation. |
|
|
|
|
| Secondary | Aldrete Score | The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach. | Posted | Mean | Standard Deviation | units on a scale | 15, 30, 45, 60, and 90 minutes after extubation. |
|
|
|
|
| Secondary | Nursing Workload Comparison | To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient). | Posted | Median | Inter-Quartile Range | units on a scale | 90 minutes after extubation |
|
|
|
|
| Secondary | Drug Stop Time to Open Eyes | time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery | Posted | Median | Inter-Quartile Range | minutes | Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes. |
|
|
|
|
| Secondary | Drug Stop Time to Recall | Time between extubation until patients could say their names. | Posted | Median | Inter-Quartile Range | minutes | Time between extubation until patients could say their names. |
|
|
|
|
| Secondary | Drug Stop Time to Fitness to Discharge | Posted | Median | Inter-Quartile Range | minutes | Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes. |
|
|
|
|
| Secondary | End Case to Post Anesthesia Care Unit (PACU) Discharge | Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge. | Posted | Median | Inter-Quartile Range | minutes | End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes. |
|
|
|
|
| Secondary | Postoperative Nausea | Indicator of whether patients had nausea or not | Posted | Number | participants | Whether patients had nausea or not, from anesthesia stop time until hospital discharge. |
|
|
|
|
| Secondary | Postoperative Vomitting | Indicator of whether patients had postoperative vomiting. | Posted | Number | participants | Whether patients had vomiting or not, from anesthesia stop time until hospital discharge. |
|
|
|
|
| Secondary | Postoperative Shivering | Indicator of whether patients had postoperative shivering. | Posted | Number | participants | Whether patients had postoperative or not, from anesthesia stop time until hospital discharge. |
|
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Dexmedetomidine | a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour. | 0 | 68 | 0 | 68 |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model. |
| t-test, 1 sided |
| < 0.001 |
| Mean Difference (Final Values) |
| -1.9 |
| 2-Sided |
| 97.5 |
| -2.8 |
| -0.9 |
| No |
| Superiority or Other |
Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test |
| Wilcoxon (Mann-Whitney) |
| < 0.001 |
| Median Difference (Final Values) |
| -5 |
| 2-Sided |
| 97.5 |
| -10 |
| -3 |
| No |
| Superiority or Other |
| Heart rate 45 minutes after extubation |
|
| Heart rate 60 minutes after extubation |
|
| Heart rate 90 minutes after extubation |
|
| SOMCT 45 minutes after extubation |
|
| SOMCT 60 minutes after extubation |
|
| SOMCT 90 minutes after extubation |
|
| Aldrete score at 45 minutes after extubation |
|
| Aldrete score at 60 minutes after extubation |
|
| Aldrete score at 90 minutes after extubation |
|