Hypotension Clinical Trial
Official title:
Evaluation of Observer Alertness/Sedation Score (OAA/S) and Bispectral Index (BIS) Parameters for Induction of General Anesthesia With Propofol in Geriatric Patients
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 observer's alertness sedation score will be compared with bispectral index-guided inductions.
Status | Recruiting |
Enrollment | 122 |
Est. completion date | April 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - T.R. Patients aged 65 and over who will undergo elective surgery under general anesthesia in the Urology Operating Room of the Ministry of Health Ankara City Hospital Exclusion Criteria: - Being under 65 years old - Those who do not have the ability to read, understand and sign the consent form - Hemodynamically unstable patients - Those who have contraindications to anesthetic drugs - Patients who do not want to participate in the study - Patients with advanced dementia - Emergency surgical procedures |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Bilkent City Hospital | Ankara | Çankaya |
Lead Sponsor | Collaborator |
---|---|
Ankara City Hospital Bilkent |
Turkey,
Chen L, Lu K, Luo T, Liang H, Gui Y, Jin S. Observer's Assessment of Alertness/Sedation-based titration reduces propofol consumption and incidence of hypotension during general anesthesia induction: A randomized controlled trial. Sci Prog. 2021 Oct;104(4) — View Citation
Devinney MJ, Berger M. Goldilocks and propofol dosage in older adults: Too much, too little, or just right? J Am Geriatr Soc. 2021 Aug;69(8):2106-2109. doi: 10.1111/jgs.17221. Epub 2021 May 8. No abstract available. — View Citation
Gurses E, Sungurtekin H, Tomatir E, Dogan H. Assessing propofol induction of anesthesia dose using bispectral index analysis. Anesth Analg. 2004 Jan;98(1):128-131. doi: 10.1213/01.ANE.0000090314.43496.1D. — View Citation
Pilge S, Zanner R, Schneider G, Blum J, Kreuzer M, Kochs EF. Time delay of index calculation: analysis of cerebral state, bispectral, and narcotrend indices. Anesthesiology. 2006 Mar;104(3):488-94. doi: 10.1097/00000542-200603000-00016. — View Citation
Rusch D, Arndt C, Eberhart L, Tappert S, Nageldick D, Wulf H. Bispectral index to guide induction of anesthesia: a randomized controlled study. BMC Anesthesiol. 2018 Jun 15;18(1):66. doi: 10.1186/s12871-018-0522-8. — View Citation
Schmidt GN, Bischoff P, Standl T, Lankenau G, Hilbert M, Schulte Am Esch J. Comparative evaluation of Narcotrend, Bispectral Index, and classical electroencephalographic variables during induction, maintenance, and emergence of a propofol/remifentanil ane — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Use of BIS for preventing hypotension (mean arterial pressure (MAP) <60 mmHg) during propofol induction in geriatric patients | The mean arterial pressure (MAP) will be recorded at 2-minute intervals for a duration of 14 minutes. | ||
Secondary | Find the differences between the input MAP and the MAP at each measurement | The mean arterial pressure (MAP) will be recorded at 2-minute intervals for a duration of 14 minutes, and the differences between the entry MAP and the MAP at each measurement will be determined. | ||
Secondary | Find the difference between input MAP and lowest MAP | Mean arterial pressure (MAP) will be recorded at 2-minute intervals for a duration of 14 minutes, and the difference between the entry MAP and the lowest MAP will be determined. | ||
Secondary | To determine the ratio of hypotensive and normotensive MAP measurements | The mean arterial pressure (MAP) will be recorded at 2-minute intervals for a duration of 14 minutes, and the ratio of hypotensive to normotensive MAP measurements will be determined. | ||
Secondary | To determine the number of patients with severe hypotension (MAP<50 mmHg) | Mean arterial pressure (MAP) will be recorded at 2-minute intervals for a duration of 14 minutes, and the number of patients experiencing severe hypotension (MAP<50 mmHg) will be determined. | ||
Secondary | To determine the number of patients receiving vasopressor therapy and the drug dosage | The mean arterial pressure (MAP) will be recorded at 2-minute intervals for a duration of 14 minutes, and the number of patients developing hypotension receiving vasopressor therapy, along with the drug dosage, will be determined. | ||
Secondary | To determine the number of patients who underwent Trendelenburg | The mean arterial pressure (MAP) will be recorded at 2-minute intervals for a duration of 14 minutes, and the number of patients with hypotension who undergo Trendelenburg positioning will be determined. | ||
Secondary | To determine the number of patients who developed tachycardia (HR>100/min) | Heart rate will be recorded at 2-minute intervals for a duration of 14 minutes, and the number of patients developing tachycardia (heart rate >100 beats per minute) during this period will be determined. | ||
Secondary | To determine the number of patients who developed hypertension (MAP>140) | The mean arterial pressure (MAP) will be recorded at 2-minute intervals for a duration of 14 minutes, and the number of patients developing hypertension (MAP >140 mmHg) will be determined. | ||
Secondary | Finding the correlation between BIS values and MAP | MAP, bispectral index, and the duration until the bispectral index reaches the range of 40-60 will be recorded at 2-minute intervals for a duration of 14 minutes. The correlation between bispectral index and MAP. |
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