The Use of Sedation Score and Bispectral Index for Induction in Geriatric Patients

NCT06232980 | Completed

• 1 other identifier: UfukTakak1
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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 observer's alertness sedation score will be compared with bispectral index-guided inductions.

Conditions

E03.155.253; Bispectral Index Monitor; Hypotension

Keywords

geriatric anesthesia; bispectral index monitor; hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Anesthesia induction group guided by BIS in geriatric patients.

ACTIVE COMPARATOR

The BIS index will be evaluated every 30 seconds. The initial dose and infusion rate will be applied as 1.5 mg/kg and 100 mg/min, respectively. In the BIS group, the target index is set between 40-60, and additional doses of 20 mg will be planned every 30 seconds until reaching this target index.

Procedure: urological surgical intervention

Observer's Alertness/Sedation Score-guided induction group in geriatric patients.

ACTIVE COMPARATOR

The initial dose will be applied as 1.5 mg/kg, and the infusion rate will be 100 mg/min. An additional 20 mg of propofol will be administered every 30 seconds until the Observer's Assessment of Alertness/Sedation (OAA/S) score reaches 1.

Procedure: urological surgical intervention

Interventions

urological surgical intervention PROCEDURE

Anesthesia induction will be performed with propofol, and ventilation will be maintained with a laryngeal mask for urological surgical procedures.

Anesthesia induction group guided by BIS in geriatric patients.; Observer's Alertness/Sedation Score-guided induction group in geriatric patients.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06530, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 33964173 RESULT

• 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.

  PMID: 29902969 RESULT

• 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.

  PMID: 16508396 RESULT

• 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.

  PMID: 14693603 RESULT

• 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 anesthesia. Anesth Analg. 2004 May;98(5):1346-53, table of contents. doi: 10.1213/01.ane.0000111209.44119.30.

  PMID: 15105213 RESULT

• 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):368504211052354. doi: 10.1177/00368504211052354.

  PMID: 34825617 RESULT

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• ayşe lafçı

  ankara bilkent city hospital, anesthesiology and reanimation clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group O: HR, SAB, DAB, OAB, SpO2, and BIS values will be recorded at 2-minute intervals for 14 minutes. A standard initial dose of 1.5 mg/kg of propofol and an infusion rate of 100 mg/min will be applied. An additional 20 mg of propofol will be administered every 30 seconds until the Observer's Assessment of Alertness/Sedation (OAA/S) score reaches 1. Group B: HR, SAB, DAB, OAB, SpO2, and BIS values will be recorded at 2-minute intervals for 14 minutes. 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.

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 31, 2024
• Study Start: September 1, 2023
• Primary Completion: March 29, 2024
• Study Completion: April 15, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)