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Clinical Trials/CTRI/2024/12/077825
CTRI/2024/12/077825Not yet recruitingNot Applicable

Correlation between Blood Pressure during Pre-operative Anaesthetic Examinations and pre-intubation Blood Pressure-An Observational Study.

Dr Moumita Das1 site in 1 country372 target enrollmentStarted: December 18, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
372
Locations
1
Primary Endpoint
To evaluate the correlation of preintubation blood pressure with that of blood pressure measured before, during and after anaesthetic check up.

Study Overview

Brief Summary

Blood pressure (BP) is the lateral force of blood pushing against the walls of arteries and it is a fundamental cardiovascular variable. It is a major determinant of therapeutic decision, routinely measured in peri operative period.

Deviation from normal BP during general anaesthesia(GA) has been clearly linked to several adverse outcomes, so it is critically important for excellent outcomes in health care. BP measured before induction/intubation is the easiest to refer as baseline BP.Many studies showed white coat hypertension (WCH) is associated with an unfavourable metabolic risk factor profile, asymptomatic organ damage, and a greater risk of future progression to high cardiovascular risk and fatal events---leading in conclusion that WCH is not clinically innocent.If WCH affects pre intubation BP as reported, a certain similar effect could be present in preoperative examination by Anaesthesiologists. Unfortunately, not many studies has been done evaluating the relationship between preoperative BP measured in clinic during preanesthetic check-up and pre intubation for GA.Hence we intend to carry out this study to examine correlation between pre intubation BP and BP measured at different times in preop period i.e. before, during, and after anaesthesiologist’s examination.

PRIMARY OBJECTIVE:

To evaluate the correlation of preintubation blood pressure with     that of blood pressure measured before,during and after anaesthetic check up.

SECONDARY OBJECTIVE:

To evaluate the difference of preintubation BP with that of BP measured before , during and after anaesthetic check up in controlled hypertensives vs non hypertensive patients.​

REFERENCES

1. Magder S. The meaning of blood pressure. Crit Care. 2018 Oct 11;22(1):257. doi: 10.1186/s13054-018-2171-1.

2. Li D, Bohringer C, Liu H. What is "normal" intraoperative blood pressure and do deviations from it really affect postoperative outcome? J Biomed Res. 2017 Jan 19;31(2):79-81. doi: 10.7555/JBR.31.20160167.

3. Totapally BR. Reliable assessment of perfusion is the Holy Grail of intensive care. Indian J Crit Care Med. 2015 Jan;19(1):1-2. doi: 10.4103/0972-5229.148626

4. BijkerJB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007;107:213–20.

5. Soo JC, Lacey S, Kluger R, Silbert BS. Defining intra-operative hypotension–a pilot comparison of blood pressure during sleep and general anaesthesia. Anaesthesia. 2011;66:354–60.

6. van Klei WA, van Waes JA, Pasma W, Kappen TH, van Wolfswinkel L, Peelen LM, Kalkman CJ. Relationship between preoperative evaluation blood pressure and preinduction blood pressure: a cohort study in patients undergoing general anesthesia. Anesth Analg. 2017;124:431–7.

7. Saugel B, Reese PC, Sessler DI, Burfeindt C, Nicklas JY, Pinnschmidt HO, Reuter DA, Südfeld S. Automated ambulatory blood pressure measurements and intra operative hypotension in patients having non-cardiac surgery with general anesthesia: a prospective observational study. Anaesthesiology. 2019;131:74–83.

8. Schonberger RB, Burg MM, Holt N, Lukens CL, Dai F, Brandt C. The relationship between preoperative and primary care blood pressure among veterans presenting from home for surgery: is there evidence for anesthesiologist-initiated blood pressure referral? AnesthAnalg. 2012;114:205–14.

9. Drummond JC, Blake JL, Patel PM, Clopton P, Schulteis G. An observational study of the influence of “white-coat hypertension” on day-of-surgery blood pressure determinations. J Neurosurg Anesthesiol.2013 ;25:154– 61.

  1.  Koibuchi, I., Kadoi, Y., Asou, C. et al. The relationship between preoperative blood

pressure during anesthetic examinations and pre-intubation blood pressure. BMC

Anesthesiol 24, 89 (2024). https://doi.org/10.1186/s12871-024-02477-x

Anesthesiol 24, 89 (2024). https://doi.org/10.1186/s12871-024-02477-x

11.Soo JC, Lacey S, Kluger R, Silbert BS. Defining intra-operative hypoten sion–a pilot

comparison of blood pressure during sleep and general anaesthesia. Anaesthesia.

2011;66:354–60.

12.Venkatesan S, et al. Cohort study of pre-operative BP and risk of 30-day mortality

after elective non-cardiac surgery. Br J Anaesth. 2017;119:65–77.

13. Friedrich S, Reis S, Meybohm P, Kranke P. Preoperative anxiety. Curr Opin

Anaesthesiol. 2022;35:674–8.

14. Kumar A, Dubey PK, Ranjan A. Assessment of anxiety in surgical patients: an observational study. Anesth Essays Res. 2019;13:503–8.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients in American Society Of Anaesthesiologists (ASA) I , II grade 2)Patients between age-18-60 years 3)Elective surgical cases.

Exclusion Criteria

  • Patients with uncontrolled Hypertension 2) Patients with valvular heart diseases 3) Patients with Cardiomyopathies 4) Patients with Sympathetic overactivity 5) Patients suffering from Secondary causes of hypertension 6)Emergency surgical cases 7)Pregnant patients 8)Patients with history of any Substance abuse 9)Patients on Psychotropic medications 10) Patients with documented malnutrition.

Outcomes

Primary Outcomes

To evaluate the correlation of preintubation blood pressure with that of blood pressure measured before, during and after anaesthetic check up.

Time Frame: Measurements of Blood | pressure taken 5 minutes before pre- anaesthetic examination, during pre-anaesthetic examination, and 5 minutes after Pre-Anaesthetic examination and immediately before intubation.

Secondary Outcomes

  • To evaluate the difference of preintubation BP with that of BP measured before, during & after anaesthetic check-up in Controlled hypertensives vs non hypertensives.(Measurements of BP taken 5 minutes before Pre-Anaesthetic check up, during Pre-)

Investigators

Sponsor
Dr Moumita Das
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Moumita Das

Gauhati Medical College and Hospital

Study Sites (1)

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