Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232980
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-01-10
Brief Title:
The Use of Sedation Score and Bispectral Index for Induction in Geriatric Patients
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Evaluation of Observer AlertnessSedation Score OAAS and Bispectral Index BIS Parameters for Induction of General Anesthesia With Propofol in Geriatric Patients
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this clinical study is to determine the effectiveness of BIS-guided propofol administration in avoiding hypotension during propofol induction in geriatric patients The primary question it aims to answer is whether the mean arterial pressure can be maintained above 60mmHg with BIS-guided propofol induction For this purpose the observers alertness sedation score will be compared with bispectral index-guided inductions
Detailed Description:
The primary aim of this study is to determine the effectiveness of BIS-guided propofol administration to avoid hypotension in propofol induction in geriatric patients Mean arterial pressure MAP below 60 mmHg is defined as hypotension The secondary aims include finding the differences between the entry MAP and the MAP at each measurement determining the difference between the entry MAP and the lowest MAP determining the ratio of hypotensive and normotensive MAP measurements determining the number of patients with severe hypotension MAP50 mmHg determining the number of patients receiving vasopressor therapy and drug dosage determining the number of patients who underwent Trendelenburg and those who developed tachycardia HR100min determining the number of patients who developed hypertension MAP140 and finding the correlation between BIS values and MAP TR In the Ministry of Health Ankara City Hospital Urology Operating Room general anesthesia will be applied and ventilation will be provided with LMA as two different approaches for patients over 65 years of age By evaluating OAAS-based propofol induction and BIS-guided propofol inductions the investigators aim to investigate whether the use of BIS reduces the risk of developing hypotension by reducing the propofol dose in anesthesia induction TR After receiving ethics committee approval at the Ministry of Health Ankara City Hospital Urology Operating Room 122 patients over the age of 65 who will receive general anesthesia and ventilation with a laryngeal mask LMA under elective conditions will be included in the study
The study will be designed as a prospective randomized controlled trial A total of 122 patients undergoing elective surgery in the urology operating room will be divided into two groups Group O and Group B using computer-assisted randomization Group O will undergo an anesthesia induction guided by OAAS while Group B will undergo a general anesthesia induction guided by BIS
After being admitted to the operating room Group O will have recorded heart rate HR in beats per minute systolic arterial blood pressure SAB in mmHg diastolic arterial blood pressure DAB in mmHg mean arterial blood pressure OAB in mmHg peripheral oxygen saturation SpO2 and BIS values Four milliliters per kilogram of appropriate balanced crystalloid solution will be administered 2 minutes after the start and HR SAB DAB OAB SpO2 and BIS values will be reevaluated These values will be recorded every 2 minutes for 14 minutes Premedication will not be administered and anesthesia induction will begin with 1 mcgkg fentanyl Many commonly used anesthesia induction agents including propofol can cause significant and even life-threatening drops in blood pressure respiratory depression and other adverse events The dose ranges of propofol decrease with age leading to the FDAs recommendation to reduce the induction dose from 2-25 mgkg in geriatric patients to 1-15 mgkg In the clinic a standard initial dose of 15 mgkg of propofol and an infusion rate of 100 mgmin are applied in geriatric patients The initial dose for both groups will be 15 mgkg and the infusion rate will be 100 mgmin An additional 20 mg of propofol will be administered every 30 seconds until the Observers Assessment of AlertnessSedation OAAS score is 1 In case of hypotension the management of hypotension vasopressor treatment Trendelenburg position fluid loading is left to the discretion of the responsible anesthesiologist Anesthesia maintenance will be provided with volatile anesthetics At the end of the procedure hemodynamic parameters SAB DAB OAB HR SpO2 BIS values Observers Assessment of AlertnessSedation Scale OASS time to reach OAAS 1 anesthesia induction drug and doses hypotension treatment and airway equipment placement time will be recorded
Upon admission to the operating room Group B will have recorded heart rate HR in beats per minute systolic arterial blood pressure SAB in mmHg diastolic arterial blood pressure DAB in mmHg mean arterial blood pressure OAB in mmHg peripheral oxygen saturation SpO2 and BIS values Four milliliters per kilogram of appropriate balanced crystalloid solution will be administered 2 minutes after the start and HR SAB DAB OAB SpO2 and BIS values will be reevaluated These values will be recorded every 2 minutes for 14 minutes Premedication will not be administered and anesthesia induction will begin with 1 mcgkg fentanyl The time delay between propofol injection and the decrease in BIS index depends on the drug transition time from the injection site to the effect site and the index calculation time Time delays between 14 and 155 seconds have been reported for the BIS index In the study the BIS index will be evaluated every 30 seconds The initial dose and infusion rate will be applied as in Group O with the target index in the BIS group being 40-60 An additional dose of 20 mg will be planned every 30 seconds until the target index is reached In case of hypotension the management of hypotension vasopressor treatment Trendelenburg position fluid loading is left to the discretion of the responsible anesthesiologist At the end of the procedure hemodynamic parameters SAB DAB OAB HR SpO2 BIS values time to reach BIS 60 Observers Assessment of AlertnessSedation Scale OASS anesthesia induction drug and doses hypotension treatment and airway equipment placement time will be recorded
The sample size calculation was performed using MedCalc 158 MedCalc Software bvba Ostend Belgium It was determined that a minimum of 122 patients 61 61 is sufficient for P1 06 P2 03 α 005 and a power of 90 1-β
The study will be designed as a prospective randomized controlled trial A total of 122 patients undergoing elective surgery in the urology operating room will be divided into two groups Group O and Group B using computer-assisted randomization Group O will undergo an anesthesia induction guided by OAAS while Group B will undergo a general anesthesia induction guided by BIS
After being admitted to the operating room Group O will have recorded heart rate HR in beats per minute systolic arterial blood pressure SAB in mmHg diastolic arterial blood pressure DAB in mmHg mean arterial blood pressure OAB in mmHg peripheral oxygen saturation SpO2 and BIS values Four milliliters per kilogram of appropriate balanced crystalloid solution will be administered 2 minutes after the start and HR SAB DAB OAB SpO2 and BIS values will be reevaluated These values will be recorded every 2 minutes for 14 minutes Premedication will not be administered and anesthesia induction will begin with 1 mcgkg fentanyl Many commonly used anesthesia induction agents including propofol can cause significant and even life-threatening drops in blood pressure respiratory depression and other adverse events The dose ranges of propofol decrease with age leading to the FDAs recommendation to reduce the induction dose from 2-25 mgkg in geriatric patients to 1-15 mgkg In the clinic a standard initial dose of 15 mgkg of propofol and an infusion rate of 100 mgmin are applied in geriatric patients The initial dose for both groups will be 15 mgkg and the infusion rate will be 100 mgmin An additional 20 mg of propofol will be administered every 30 seconds until the Observers Assessment of AlertnessSedation OAAS score is 1 In case of hypotension the management of hypotension vasopressor treatment Trendelenburg position fluid loading is left to the discretion of the responsible anesthesiologist Anesthesia maintenance will be provided with volatile anesthetics At the end of the procedure hemodynamic parameters SAB DAB OAB HR SpO2 BIS values Observers Assessment of AlertnessSedation Scale OASS time to reach OAAS 1 anesthesia induction drug and doses hypotension treatment and airway equipment placement time will be recorded
Upon admission to the operating room Group B will have recorded heart rate HR in beats per minute systolic arterial blood pressure SAB in mmHg diastolic arterial blood pressure DAB in mmHg mean arterial blood pressure OAB in mmHg peripheral oxygen saturation SpO2 and BIS values Four milliliters per kilogram of appropriate balanced crystalloid solution will be administered 2 minutes after the start and HR SAB DAB OAB SpO2 and BIS values will be reevaluated These values will be recorded every 2 minutes for 14 minutes Premedication will not be administered and anesthesia induction will begin with 1 mcgkg fentanyl The time delay between propofol injection and the decrease in BIS index depends on the drug transition time from the injection site to the effect site and the index calculation time Time delays between 14 and 155 seconds have been reported for the BIS index In the study the BIS index will be evaluated every 30 seconds The initial dose and infusion rate will be applied as in Group O with the target index in the BIS group being 40-60 An additional dose of 20 mg will be planned every 30 seconds until the target index is reached In case of hypotension the management of hypotension vasopressor treatment Trendelenburg position fluid loading is left to the discretion of the responsible anesthesiologist At the end of the procedure hemodynamic parameters SAB DAB OAB HR SpO2 BIS values time to reach BIS 60 Observers Assessment of AlertnessSedation Scale OASS anesthesia induction drug and doses hypotension treatment and airway equipment placement time will be recorded
The sample size calculation was performed using MedCalc 158 MedCalc Software bvba Ostend Belgium It was determined that a minimum of 122 patients 61 61 is sufficient for P1 06 P2 03 α 005 and a power of 90 1-β
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None