NCT06155461

Brief Summary

General anesthesia is frequently used in daily clinical practice. Elderly patients often require a higher level of care than younger patients during the perioperative period, with higher health care costs. Strategies to optimize anesthesia care to reduce complications and improve outcomes in elderly surgical patients will also be of great value to the individual patients and society.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 19, 2023

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the predictive value of pre-induction IVC

    Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension

    5 minutes

Secondary Outcomes (2)

  • Incidence of post-induction hypotension

    5 minutes

  • Correlation between each of IVC collapsibility index with the percentage of the maximum decrease in mean arterial pressure after induction of anesthesia

    5 minutes

Interventions

to evaluate the ability of preoperative ultrasound measurements of IVC to aorta diameter index and the inferior vena cava collapsibility index (IVCCI) for predicting post induction hypotension after general anesthesia in geriatric patients.

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective surgery under general anesthesia, ASA I, II

You may qualify if:

  • Adult patients ( 60 - 85 ) years old of both sexes with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for elective surgeries under general anesthesia.

You may not qualify if:

  • Refusal to join the study.
  • Mental and psychiatric disorders (un co-operative patients).
  • Emergency operations
  • ASA physical status \> II
  • Dyspnea, respiratory distress, un-compensated respiratory disease (generalized wheezes, defective functional capacity, peripheral O2 saturation less than 90% on room air )
  • patients with uncontrolled hypertension, Systolic blood pressure ≥ 180 mmHg
  • IVC non visualized
  • Patients with increased intra-abdominal pressure (intra-abdominal mass compressing IVC).
  • anticipated or accidental discovered difficult airway
  • patients taking angiotensin converting enzyme inhibitors or angiotensin receptors blockers, documented heart failure, elevated pulmonary arterial pressure \> 40 mmHg, significant valvular heart disease, significant carotid stenosis, peripheral vascular diseases, unstable angina or cardiac ejection fraction less than 40%, implanted pacemaker or cardioversion , known cases of abdominal aortic abnormality as aneurysm or previous operations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ahmed Saied, Professor

    Al-Azhar University, Faculty of medicine for boys

    STUDY CHAIR

Central Study Contacts

Mohammad Al-Bahar, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2023

First Posted

December 4, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 15, 2024

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations