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

Primary Purpose

Anemia, Cardiomyopathies, Pulmonary Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Etomidate
Ketamine Hydrochloride
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anemia focused on measuring Etomidate, Ketamine, Colonoscopy, Upper endoscopyPulmonary Hy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Khalid University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Etomidate

Ketamine-Etomidate

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of perioperative cardiopulmonary complications
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. Bradycardia: decrease of HR < 50/min, and this was treated by atropine 0.5 mg IV boluses. Apnea: spontaneous breathing > 30 sec, or SpO2 < 85%, and this was treated by assisted manual ventilation using AMBU bag and face mask.
Level of pateint satisfaction
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).

Full Information

First Posted
April 20, 2021
Last Updated
April 20, 2021
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT04857450
Brief Title
Anesthesia for Upper Endoscopy and Colonoscopy in Cardiac Patients With Acute Anemia
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
November 20, 2021 (Anticipated)
Study Completion Date
December 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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: 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. Bradycardia: decrease of HR < 50/min, and this will be treated by atropine 0.5 mg IV boluses. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Cardiomyopathies, Pulmonary Hypertension
Keywords
Etomidate, Ketamine, Colonoscopy, Upper endoscopyPulmonary Hy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
All participants including care provider and outcome assessors will unaware of group allocation.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Etomidate
Arm Type
Sham Comparator
Arm Description
Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed.
Arm Title
Ketamine-Etomidate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Etomidate
Intervention Description
Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by Etomidate 0.05 mg/kg IV and repeated when needed.
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
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 Measure Information:
Title
Measurement of serum cortisl level
Description
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
Time Frame
From preoperative baseline to post operative after 6 hours
Secondary Outcome Measure Information:
Title
Incidence of perioperative cardiopulmonary complications
Description
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. Bradycardia: decrease of HR < 50/min, and this was treated by atropine 0.5 mg IV boluses. Apnea: spontaneous breathing > 30 sec, or SpO2 < 85%, and this was treated by assisted manual ventilation using AMBU bag and face mask.
Time Frame
From preoperative till postoperative 6 hours
Title
Level of pateint satisfaction
Description
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).
Time Frame
From preoperative till full recovery after 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa M Elhamamsy, MD
Phone
00966568799134
Email
mostafah333@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rubie M. de Ocampo
Phone
00966114691531
Email
rdeocampo@ksu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubie M de Ocampo
Organizational Affiliation
INSTITUTIONAL REVIEW BOARD King Saud University
Official's Role
Study Director
Facility Information:
Facility Name
King Khalid University Hospital
City
Riyadh
ZIP/Postal Code
11472
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubie M de Ocampo
Phone
00966114691531
Email
rdeocampo@ksu.edu.sa
First Name & Middle Initial & Last Name & Degree
Mostafa M Elhamamsy, MD
Phone
00966568799134
Email
mostafah333@gmail.co

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD
IPD Sharing Time Frame
January 2022
IPD Sharing Access Criteria
IPD data will be available on request through email.
Citations:
PubMed Identifier
10966311
Citation
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Anesthesia for Upper Endoscopy and Colonoscopy in Cardiac Patients With Acute Anemia

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