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

NCT04857450 | Unknown DMC

• 1 other identifier: E-20-4814
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Cardiomyopathies; Pulmonary Hypertension

Keywords

Etomidate; Ketamine; Colonoscopy; Upper endoscopyPulmonary Hy

Outcome Measures

Primary Outcomes (1)

• Measurement of serum cortisl level

  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

  From preoperative baseline to post operative after 6 hours

Secondary Outcomes (2)

• Incidence of perioperative cardiopulmonary complications

  From preoperative till postoperative 6 hours

• Level of pateint satisfaction

  From preoperative till full recovery after 6 hours

Study Arms (2)

Etomidate

SHAM COMPARATOR

Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed.

Drug: Etomidate

Ketamine-Etomidate

ACTIVE COMPARATOR

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

Interventions

Etomidate DRUG

Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by Etomidate 0.05 mg/kg IV and repeated when needed.

Etomidate

Ketamine Hydrochloride DRUG

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.

Ketamine-Etomidate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Khalid University Hospital

Riyadh, 11472, Saudi Arabia

RECRUITING

Related Publications (14)

• Corwin HL, Krantz SB. Anemia of the critically ill: "acute" anemia of chronic disease. Crit Care Med. 2000 Aug;28(8):3098-9. doi: 10.1097/00003246-200008000-00079. No abstract available.

  PMID: 10966311 RESULT

• van Leerdam ME, Vreeburg EM, Rauws EA, Geraedts AA, Tijssen JG, Reitsma JB, Tytgat GN. Acute upper GI bleeding: did anything change? Time trend analysis of incidence and outcome of acute upper GI bleeding between 1993/1994 and 2000. Am J Gastroenterol. 2003 Jul;98(7):1494-9. doi: 10.1111/j.1572-0241.2003.07517.x.

  PMID: 12873568 RESULT

• Colle I, Wilmer A, Le Moine O, Debruyne R, Delwaide J, Dhondt E, Macken E, Penaloza A, Piessevaux H, Stephenne X, Van Biervliet S, Laterre PF. Upper gastrointestinal tract bleeding management: Belgian guidelines for adults and children. Acta Gastroenterol Belg. 2011 Mar;74(1):45-66.

  PMID: 21563653 RESULT

• Regula J, Sokol-Kobielska E. Sedation in endoscopy: when and how. Best Pract Res Clin Gastroenterol. 2008;22(5):945-57. doi: 10.1016/j.bpg.2008.06.002.

  PMID: 18790440 RESULT

• Habibi MR, Baradari AG, Soleimani A, Emami Zeydi A, Nia HS, Habibi A, Onagh N. Hemodynamic responses to etomidate versus ketamine-thiopental sodium combination for anesthetic induction in coronary artery bypass graft surgery patients with low ejection fraction: a double-blind, randomized, clinical trial. J Clin Diagn Res. 2014 Oct;8(10):GC01-5. doi: 10.7860/JCDR/2014/10237.5006. Epub 2014 Oct 20.

  PMID: 25478364 RESULT

• Bovill JG. Intravenous anesthesia for the patient with left ventricular dysfunction. Semin Cardiothorac Vasc Anesth. 2006 Mar;10(1):43-8. doi: 10.1177/108925320601000108.

  PMID: 16703233 RESULT

• Forman SA. Clinical and molecular pharmacology of etomidate. Anesthesiology. 2011 Mar;114(3):695-707. doi: 10.1097/ALN.0b013e3181ff72b5.

  PMID: 21263301 RESULT

• Wanscher M, Tonnesen E, Huttel M, Larsen K. Etomidate infusion and adrenocortical function. A study in elective surgery. Acta Anaesthesiol Scand. 1985 Jul;29(5):483-5. doi: 10.1111/j.1399-6576.1985.tb02238.x.

  PMID: 4036533 RESULT

• Heidari SM, Loghmani P. Assessment of the effects of ketamine-fentanyl combination versus propofol-remifentanil combination for sedation during endoscopic retrograde cholangiopancreatography. J Res Med Sci. 2014 Sep;19(9):860-6.

  PMID: 25535501 RESULT

• Rai K, Hegde AM, Goel K. Sedation in uncooperative children undergoing dental procedures: a comparative evaluation of midazolam, propofol and ketamine. J Clin Pediatr Dent. 2007 Fall;32(1):1-4. doi: 10.17796/jcpd.32.1.v74872j8n74qu81k.

  PMID: 18274461 RESULT

• Zed PJ, Mabasa VH, Slavik RS, Abu-Laban RB. Etomidate for rapid sequence intubation in the emergency department: is adrenal suppression a concern? CJEM. 2006 Sep;8(5):347-50. doi: 10.1017/s1481803500014044.

  PMID: 17338847 RESULT

• Varga I, Racz K, Kiss R, Futo L, Toth M, Sergev O, Glaz E. Direct inhibitory effect of etomidate on corticosteroid secretion in human pathologic adrenocortical cells. Steroids. 1993 Feb;58(2):64-8. doi: 10.1016/0039-128x(93)90054-q.

  PMID: 8387232 RESULT

• Wu GN, Xu HJ, Liu FF, Wu X, Zhou H. Low-Dose Ketamine Pretreatment Reduces the Incidence and Severity of Myoclonus Induced by Etomidate: A Randomized, Double-Blinded, Controlled Clinical Trial. Medicine (Baltimore). 2016 Feb;95(6):e2701. doi: 10.1097/MD.0000000000002701.

  PMID: 26871805 RESULT

• Elhamamsy MM, Aldemerdash AM, Zahran FB, Ezz GFM, AlSaud SA, Boules ML, Abdelhady MA, Hamed MA. Effects of adding low-dose ketamine to etomidate on serum cortisol levels in critically ill cardiac patients: a randomized clinical trial. BMC Anesthesiol. 2022 Apr 21;22(1):114. doi: 10.1186/s12871-022-01654-0.

  PMID: 35448950 DERIVED

MeSH Terms

Conditions

Anemia; Cardiomyopathies; Hypertension, Pulmonary

Interventions

Etomidate; Ketamine

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Rubie M de Ocampo

  INSTITUTIONAL REVIEW BOARD King Saud University

  STUDY DIRECTOR

Central Study Contacts

Mostafa M Elhamamsy, MD

CONTACT

00966568799134; mostafah333@gmail.com

Rubie M. de Ocampo

CONTACT

00966114691531; rdeocampo@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All participants including care provider and outcome assessors will unaware of group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Consultant

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: November 20, 2020
• Primary Completion: November 20, 2021
• Study Completion: December 20, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: January 2022
• Access Criteria: IPD data will be available on request through email.

Locations

SA (1)