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Anesthesia for Upper Endoscopy and Colonoscopy in Cardiac Patients With Acute Anemia

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ClinicalTrials.gov Identifier: NCT04857450
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Mostafa Mohammed Elsaid Elhamamsy, King Saud University

Brief Summary:
The aim of this study was to try to reduce the required dose of etomidate used in anesthesia for upper endoscopy and colonoscopy in critically ill cardiac patients who complain of severe anemia in cardiac intensive care units by using a low dose of ketamine, which helps to reduce the side effects of etomidate, the most important of which is its suppressive effect on the adrenal gland and the secretion of cortisol in such critical cases, while maintaining hemodynamic stability, and the patient's satisfaction.

Condition or disease Intervention/treatment Phase
Anemia Cardiomyopathies Pulmonary Hypertension Drug: Etomidate Drug: Ketamine Hydrochloride Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Sixty adult cardiac patients, older than 18 with ASA II or III physical status who underwent upper endoscopy together with colonoscopy for management of acute anemia in the cardiac intensive care units from November 2020 - October 2021. They were randomly divided into two groups. All patients received 0.05 mg/kg midazolam and 1µg/kg fentanyl slow IV as basal sedation and analgesia, then :

Group (E): Received Etomidate 0.1 mg/kg IV over 20-30 seconds, followed by 0.05 mg/kg IV and repeated when needed, and Group (KE): Received Ketamine 0.5 mg/kg IV over 20-30 seconds followed by Etomidate 0.05 mg/kg IV over 20-30 seconds and repeated when needed.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: All participants including care provider and outcome assessors will unaware of group allocation.
Primary Purpose: Supportive Care
Official Title: Anesthesia for Upper Endoscopy and Colonoscopy in Cardiac Patients With Acute Anemia: Pretreatment With Low-dose Ketamine Can Reduce the Dose of Etomidate. A Randomized Clinical Trial.
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : November 20, 2021
Estimated Study Completion Date : December 20, 2021


Arm Intervention/treatment
Sham Comparator: Etomidate
Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed.
Drug: Etomidate
Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by Etomidate 0.05 mg/kg IV and repeated when needed.

Active Comparator: Ketamine-Etomidate
Received Ketamine 0.5 mg/kg IV over 30 seconds then Etomidate 0.1 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed.
Drug: Ketamine Hydrochloride
Received Ketamine 0.5 mg/kg IV over 30 seconds then Etomidate 0.1 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed.




Primary Outcome Measures :
  1. Measurement of serum cortisl level [ Time Frame: From preoperative baseline to post operative after 6 hours ]
    Primary goal was to prove that if we combined etomidate with small dose of ketamine, the level of cortisol will be decreased to a lesser extent than in case we use etomidate alone. measurement will be done peoperative and 6 hours after the procedure


Secondary Outcome Measures :
  1. Incidence of perioperative cardiopulmonary complications [ Time Frame: From preoperative till postoperative 6 hours ]
    1. Hypotension: decrease of baseline systolic blood pressure (SBP) >30%, or decrease of baseline diastolic blood pressure (DBP) >30%, and this was treated by phenylephrine 100-200 µg IV boluses.
    2. Bradycardia: decrease of HR < 50/min, and this was treated by atropine 0.5 mg IV boluses.
    3. Apnea: spontaneous breathing > 30 sec, or SpO2 < 85%, and this was treated by assisted manual ventilation using AMBU bag and face mask.

  2. Level of pateint satisfaction [ Time Frame: From preoperative till full recovery after 6 hours ]

    After full recovery and when the patients were alert enough to express their attitude regarding the intra-procedural events, they will be asked to score their level of satisfaction during the procedure in terms of recalling any painful or other undesirable intra-procedural events.

    Patient's satisfaction level will be assessed with a Likert five-item scoring system :

    (1 = Not satisfied at all, 2 = slightly satisfied, 3 = somewhat satisfied, 4 = very satisfied, and 5 = extremely satisfied).




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Age 18 - 65 years,
  • ASA II-III
  • Ejection fraction (EF) > 30%.

Exclusion Criteria:- Poor left ventricular function (ejection fraction < 30%).

  • Recent myocardial infarction (last seven days),
  • Patients with uncontrolled chronic disease (uncontrolled diabetes mellitus (DM) and hypertension),
  • Known history of hypersensitivity to midazolam, fentanyl, etomidate, Or ketamine,
  • Severe respiratory, hepatic or renal failure,
  • History of neurological disorders or convulsions,
  • In addition, any need for further anesthetic drug administration other than the study protocol was another exclusion criterion of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857450


Contacts
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Contact: Mostafa M Elhamamsy, MD 00966568799134 mostafah333@gmail.com
Contact: Rubie M. de Ocampo 00966114691531 rdeocampo@ksu.edu.sa

Locations
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Saudi Arabia
King Khalid University Hospital Recruiting
Riyadh, Saudi Arabia, 11472
Contact: Rubie M de Ocampo    00966114691531    rdeocampo@ksu.edu.sa   
Contact: Mostafa M Elhamamsy, MD    00966568799134    mostafah333@gmail.co   
Sponsors and Collaborators
King Saud University
Investigators
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Study Director: Rubie M de Ocampo INSTITUTIONAL REVIEW BOARD King Saud University
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mostafa Mohammed Elsaid Elhamamsy, Anesthesia Consultant, King Saud University
ClinicalTrials.gov Identifier: NCT04857450    
Other Study ID Numbers: E-20-4814
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: January 2022
Access Criteria: IPD data will be available on request through email.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mostafa Mohammed Elsaid Elhamamsy, King Saud University:
Etomidate
Ketamine
Colonoscopy
Upper endoscopyPulmonary Hy
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Cardiomyopathies
Anemia
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Ketamine
Etomidate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives