AnemiaNCT04857450
Anesthesia for Upper Endoscopy and Colonoscopy in Cardiac Patients With Acute Anemia
A study testing Etomidate and Ketamine Hydrochloride in people with Anemia and Cardiomyopathies, run by King Saud University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anemia, Cardiomyopathies, Pulmonary Hypertension
- What is being tested?
- Etomidate and Ketamine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Nov 2020to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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),
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Khalid University Hospital
Riyadh, 11472
Rubie M de Ocampo, 00966114691531, rdeocampo@ksu.edu.sa
Mostafa M Elhamamsy, MD, 00966568799134, mostafah333@gmail.co
About this study
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.
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.
Read the 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.
- Conditions
- Anemia, Cardiomyopathies, Pulmonary Hypertension
- Being tested
- Etomidate, Ketamine Hydrochloride
- Keywords
- Etomidate, Ketamine, Colonoscopy, Upper endoscopyPulmonary Hy
- Medical subject headings
- Anemia, Cardiomyopathies, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by Etomidate 0.05 mg/kg IV and repeated when needed.
Ketamine HydrochlorideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Etomidate | Sham comparator | Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed. Receives: 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. Receives: Drug: Ketamine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From preoperative baseline to post operative after 6 hours
Secondary outcomes (2)
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.
Measured: From preoperative till postoperative 6 hours
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).
Measured: From preoperative till full recovery after 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start20 Nov 2020
- Primary completion20 Nov 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohammed Elsaid Elhamamsy, King Saud University
- Investigators
- Rubie M de Ocampo, Study director, INSTITUTIONAL REVIEW BOARD King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857450
- Sponsor's protocol ID
- E-20-4814
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
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.
PubMed 10966311van 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.
PubMed 12873568Colle 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.
PubMed 21563653Regula 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.
PubMed 18790440Habibi 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.
PubMed 25478364Bovill JG. Intravenous anesthesia for the patient with left ventricular dysfunction. Semin Cardiothorac Vasc Anesth. 2006 Mar;10(1):43-8. doi: 10.1177/108925320601000108.
PubMed 16703233Forman SA. Clinical and molecular pharmacology of etomidate. Anesthesiology. 2011 Mar;114(3):695-707. doi: 10.1097/ALN.0b013e3181ff72b5.
PubMed 21263301Wanscher 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.
PubMed 4036533Heidari 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.
PubMed 25535501Rai 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.
PubMed 18274461Zed 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.
PubMed 17338847Varga 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.
PubMed 8387232Wu 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.
PubMed 26871805Elhamamsy 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.
PubMed 35448950
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04857450
- Acronym / sponsor ID
- E-20-4814
- Conditions
- Anemia, Cardiomyopathies, Pulmonary Hypertension
- Keywords
- Etomidate, Ketamine, Colonoscopy, Upper endoscopyPulmonary Hy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 Nov 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Etomidate | Sham comparator | Drug: EtomidateReceived Etomidate 0.2 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed. |
| Ketamine-Etomidate | Active comparator | Drug: Ketamine HydrochlorideReceived 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- - 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),
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtomidateReceived Etomidate 0.2 mg/kg IV over 30 seconds, followed by Etomidate 0.05 mg/kg IV and repeated when needed. | Drug | Etomidate |
| Ketamine HydrochlorideReceived 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-Etomidate |
Primary outcome
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
2 secondary outcomes
Incidence of perioperative cardiopulmonary complications
Time frame: From preoperative till postoperative 6 hours
Level of pateint satisfaction
Time frame: From preoperative till full recovery after 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Results publication: PubMed 10966311Corwin 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.
- Results publication: PubMed 12873568van 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.
- Results publication: PubMed 21563653Colle 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.
- Results publication: PubMed 18790440Regula 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.
- Results publication: PubMed 25478364Habibi 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.
- Results publication: PubMed 16703233Bovill JG. Intravenous anesthesia for the patient with left ventricular dysfunction. Semin Cardiothorac Vasc Anesth. 2006 Mar;10(1):43-8. doi: 10.1177/108925320601000108.
- Results publication: PubMed 21263301Forman SA. Clinical and molecular pharmacology of etomidate. Anesthesiology. 2011 Mar;114(3):695-707. doi: 10.1097/ALN.0b013e3181ff72b5.
- Results publication: PubMed 4036533Wanscher 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.
- Results publication: PubMed 25535501Heidari 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.
- Results publication: PubMed 18274461Rai 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.
- Results publication: PubMed 17338847Zed 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.
- Results publication: PubMed 8387232Varga 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.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubie M de Ocampo study director
INSTITUTIONAL REVIEW BOARD King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etomidate and Ketamine Hydrochloride in people with Anemia and Cardiomyopathies, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa M Elhamamsy, MD (00966568799134, mostafah333@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of serum cortisl level (time frame: From preoperative baseline to post operative after 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04857450, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.