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

April 20, 2021 updated by: Mostafa Mohammed Elsaid Elhamamsy, King Saud University

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This Prospective Randomized Clinical Trial will be done in the period from November 2020 - October 2021, after approval of our local ethical committee, and based upon written informed consent, included sixty cardiac patients, ASA physical statuses III or IV, admitted in CCU and SICU, and scheduled for upper endoscopy together with colonoscopy for diagnosis and management of acute anemia.

The study will be performed in the CCU or SICU with the presence of all emergency equipment's. The gastroenterologist who performed the colonoscopies will be blinded from the type of drugs used for sedation.

All patients will receive a colonic preparation protocol before the operation, and bowel cleansing will be performed, and all patients will be fasting 8 hours before the procedures.

Anesthesia management:

After establishment of IV access, standard monitoring will be performed (noninvasive blood pressure, ECG, SpO2, and BIS using (Masimo) monitor).

Nasal cannula for oxygen (6 l/min) will be connected to all patients, then midazolam 0.03mg/kg IV as a premedication, and fentanyl 1µg/kg IV will be injected to all patients.

By the means of sealed envelope technique, patients will be randomly divided into two groups:

Group (E): Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed.

Group (KE): 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.

The additional dose of etomidate will be determined by the anesthesiologist to achieve 4-5 sedation level of Ramsay Sedation Scale or BIS above 60.

Complications during procedure will be considered and defined as:

  1. Hypotension: decrease of baseline systolic blood pressure (SBP) >30%, or decrease of baseline diastolic blood pressure (DBP) >30%, and this will be treated by phenylephrine 100-200 µg IV boluses.
  2. Bradycardia: decrease of HR < 50/min, and this will be treated by atropine 0.5 mg IV boluses.
  3. Apnea: spontaneous breathing > 30 sec, or SpO2 < 85%, and this will be treated by assisted manual ventilation using AMBU bag and face mask.

During the procedure the level of sedation will be assessed every five minutes after administration of anesthetic drugs using Ramsay Sedation Scale (RSS) [18]: (1 = Anxious or restless or both, 2 = Cooperative, 3 = Responding to commands, 4 = Brisk response to stimulus, 5 = Sluggish response to stimulus, 6 = No response to stimulus), in addition to BIS.

The use of standard monitoring will be continued until the patients were fully awake. At the end of the procedure, total etomidate dose, the duration of the procedure, and the recovery time of the patients were recorded.

After full recovery and when the patients are 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 willbe assessed with a Likert five-item scoring system [19]:

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

Serum cortisol before and 6 hours after the procedure will be estimated in this clinical trial to calculate the percentage of suppression in both groups.

Statistical Analysis:

Sample size was calculated using: Calculator.net Home / math / sample size calculator. Sample size of 30 cases in each group was calculated to have at least an 80% power to detect the expected differences between the two groups with respect to the primary goal.

Group comparison willbe performed between groups E and KE to analyze differences. Mean, standard deviation (SD), median, frequency, and percentage (%) will be used in the descriptive statistics of the quantitative and qualitative data. Mann-Whitney U test will be used in the analysis of quantitative independent data. Chi-square test will be used to analyze qualitative independent data, and Fischer's test will be used when chi-square test conditions were not met. For comparison of the sedation score data, hemodynamic parameters and SpO2 values, the repeated measurement analysis will be used. P value <0.05 will be considered statistically significant. SPSS v23.0 program will be used for all the analysis.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From preoperative baseline to post operative after 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From preoperative till postoperative 6 hours
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).
From preoperative till full recovery after 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Investigators

  • Study Director: Rubie M de Ocampo, INSTITUTIONAL REVIEW BOARD King Saud University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2020

Primary Completion (ANTICIPATED)

November 20, 2021

Study Completion (ANTICIPATED)

December 20, 2021

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (ACTUAL)

April 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-20-4814

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

IPD Sharing Time Frame

January 2022

IPD Sharing Access Criteria

IPD data will be available on request through email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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