Effect of DrugsNCT03600506
Dexmedetomidine Adjuvant to General Anesthesia of Abdominal Hysterectomy
A study testing Dexmedetomidine in people with Effect of Drugs, run by Suez Canal University.
Trial summary
To assess the effect of perioperative Dexmedetomidine infusion on Interleukin 6 and cortisol level in patients undergoing general anesthesia for total abdominal hysterectomy Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Effect of Drugs
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Jan 2020
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiology physical status Grade I = (normal healthy patients)
- American Society of Anesthesiology physical status Grade II = (patients with mild systemic disease and no functional limitations)
- Patients scheduled for abdominal hysterectomy.
Who cannot join
- Pre-operative regular medication with opioids and benzodiazepines, alcohol abuse, known sleep disturbance, known endocrine disease.
- Known allergy to Dexmedetomidine.
- Heart block greater than first degree.
- Medication known to affect the sympathetic response or hormonal secretion.
- Smokers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Dexmedetomidine as an Adjuvant to General Anesthesia in Patients Undergoing Elective Abdominal Hysterectomy
To assess the effect of perioperative Dexmedetomidine infusion on Interleukin 6 and cortisol level in patients undergoing general anesthesia for total abdominal hysterectomy
Read the detailed description
Following the departmental research committee approval and informed patient's consent, 52 patients, undergoing abdominal hysterectomy in Suez Canal University Hospital, will be randomly assigned to one of the two groups (Dexmedetomidine and Placebo) using a table of random numbers.
Patients will be fasting for 6 - 8 hours. All patients will receive oral Midazolam (7.5 mg), and oral Ranitidine (150mg) administered 90 min before arrival in the operating room with a sip of water.
All patients will receive before induction, normal saline 10 ml/kg body weight over 10-15 minutes. Subsequently, intravenous fluid administration will be done according to the need of each patient.
All operations will start between 08:30 am and 09:30 am, to minimize variations in cortisol level.
All patients will receive the Drug of study 10 minutes before induction of anesthesia till the start of wound closure in the form of:
Group (D): Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. Group (C): Normal saline prepared in a syringe with the same volume as Dexmedetomidine to assure blinding.
Doses will be calculated, diluted in 50 ml of normal saline and given intravenously by a syringe pump over 10 minutes initially and then over 1 hour till the start of wound closure.
All drugs of the study will be prepared by an independent anesthesiologist who will not share in the study and then selected and given by another one blinded for the content of each syringe.
Airway devices, anesthesia machine, ventilator, flowmeters and monitors will be checked promptly.
Another wide-bore I.V cannula will be inserted in case of blood transfusion.
Monitoring equipment's (Datex-Ohmeda™) will be attached to the patient including 3-leads ECG, non-invasive arterial blood pressure, pulse oximeter and capnograph after tracheal intubation.
The depth of anesthesia will be monitored with Entropy device. The Entropy electrodes will be placed on the forehead and on the lateral angle of orbit and connected to (Datex-Ohmeda™). The target Entropy range will be 40-60 for surgical anesthesia.
Induction of anesthesia will be performed by Propofol 2 mg/kg followed by cis-atracurium 0.15 mg/kg and fentanyl 1 mcg/kg given intravenously after pre-oxygenation with 100% oxygen for at least 3 minutes.
Patients will be manually ventilated with 100% oxygen till intubation after 2 min and with Entropy value of 60 to 40 by Macintosh laryngoscope and appropriate size endotracheal tube.
Maintenance of anesthesia will be carried out by isoflurane varying its end tidal concentration to keep Entropy in the range of 55 to 40 with Air:Oxygen mixture 0.3 fraction of oxygen and flow rate of 2 liters/minute in completely closed circuit.
Cis-atracurium 0.03 mg/kg guided by neuromuscular monitor Train Of Four (TOF) will be used for muscle relaxation.
Hemodynamics (mean arterial blood pressure and heart rate) will be maintained within 25 % of baseline measures.
Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings within 2-3 min will be managed by I.V bolus of Fentanyl 0.5 mcg/kg and any decrease of MAP or HR less than 25 % on two consecutive readings within 2-3 min will be managed by I.V bolus of ephedrine 5 mg or atropine 0.5 mg respectively.
The infusion of study medication will be discontinued if the hypotension persisted > 5 minutes after these interventions upon return of the MAP or HR to within 25% of the baseline value, the study medication infusion will be resumed at 50% of the initial infusion rate and then gradually increased to the initial infusion rate.
The infusion of study medication will be discontinued at the start of wound closure. Upon completion of wound closure, isoflurane will be discontinued and the flow rate will be increased to 5 L/min of 100% Oxygen and residual neuromuscular block will be reversed with neostigmine, 0.05 mg/kg IV, and atropine 0.25 mg/kg IV. The trachea will be extubated when the patient is fully awake. Transfer to the recovery room will be done when the patient scored 7 and above using the modified Aldrete scoring system.
On emergence from anesthesia and immediately in post anesthesia care unit, analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h), will be used in all groups.
The whole technique and anesthetic procedures will be performed by the same anesthesiologist to avoid as much as possible the inter-individual skill variations.
- Conditions
- Effect of Drugs
- Being tested
- Dexmedetomidine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Selective α2-agonist sympatholytic drug
Patients will receive infusion of study drug intravenously 10 minutes before induction of anesthesia as 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr till the start of wound closure.
PlaceboDrug
Also called Normal Saline
Fifty ml of Placebo (normal saline) will be prepared and given intravenously by a syringe pump over 10 minutes initially and then over 1 hour till the start of wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Intervention drug of the study Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Normal Saline (Placebo) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Interleukin 6 (IL6)
Measurement of Serum Serum Interleukin 6 in picogram / milliliter
Measured: At starting drug infusion (10 minutes before induction of anesthesia) and then 2 hours after induction of anesthesia and 6 hours postoperatively
Secondary outcomes (10)
Change in Serum Cortisol
Measurement of Serum Cortisol in microgram/ deciliter
Measured: At starting drug infusion (10 minutes before induction of anesthesia) and then 2 hours after induction of anesthesia and 6 hours postoperatively
Change in Mean arterial blood pressure
Changes in Mean Arterial Blood Pressure (MABP) in mmHg (not systolic or diastolic) with intubation, extubation and throughout surgery
Measured: Mean Arterial Blood Pressure before starting infusion of the study drug, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation
Change in Heart Rate (HR)
Changes in Heart Rate (HR) with intubation, extubation and throughout surgery
Measured: HR before starting infusion of the study drug, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation
Morphine Consumption in patient controlled analgesia (PCA)
Morphine Consumption in PCA in first 24 hours postoperatively in mg
Measured: Twenty four hours after attachment of patient controlled analgesia in postoperative care unit
Fentanyl consumption in microgram using questionnaire
Total intraoperative Fentanyl consumption in microgram
Measured: During intraoperative time
Isoflurane in milliliter using the Ventilator reading
Total intraoperative Isoflurane consumption in ml
Measured: During intraoperative time
Ephedrine in milligram using quessionnaire
Total amount of ephedrine in mg given because of hypotension and number of times of discontinuation of study medication.
Measured: During intraoperative time
Atropine in milligram using quessionnaire
Total amount of Atropine in mg given because of bradycardia and number of times of discontinuation of study medication.
Measured: During intraoperative time
Extubation time
Time for extubation of tracheal tube in minutes
Measured: Extubation
Visual Analogue Scale VAS of Pain intensity
Pain scale measurement for postoperative assessment of pain consisting from 0 to 10 representing 0 as no pain and 10 as the most imaginable pain treating the patient if VAS > 3
Measured: VAS (visual analogue scale) at 1, 2, 4, 8, 12 and 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugsStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed A Elsadany, MD, Suez Canal University
- Investigators
- Mohamed A Elsadany, MD, Principal investigator, Anesthesia Department, Faculty of Medicine, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600506
- Sponsor's protocol ID
- 3400
- Status last verified
- Aug 2018
- First submitted
- 26 Jun 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as an Adjuvant to General Anesthesia in Patients Undergoing Elective Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT03600506
- Acronym / sponsor ID
- 3400
- Conditions
- Effect of Drugs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 26 Jul 2018 (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.
To assess the effect of perioperative Dexmedetomidine infusion on Interleukin 6 and cortisol level in patients undergoing general anesthesia for total abdominal hysterectomy
Detailed description
Following the departmental research committee approval and informed patient's consent, 52 patients, undergoing abdominal hysterectomy in Suez Canal University Hospital, will be randomly assigned to one of the two groups (Dexmedetomidine and Placebo) using a table of random numbers.
Patients will be fasting for 6 - 8 hours. All patients will receive oral Midazolam (7.5 mg), and oral Ranitidine (150mg) administered 90 min before arrival in the operating room with a sip of water.
All patients will receive before induction, normal saline 10 ml/kg body weight over 10-15 minutes. Subsequently, intravenous fluid administration will be done according to the need of each patient.
All operations will start between 08:30 am and 09:30 am, to minimize variations in cortisol level.
All patients will receive the Drug of study 10 minutes before induction of anesthesia till the start of wound closure in the form of:
Group (D): Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. Group (C): Normal saline prepared in a syringe with the same volume as Dexmedetomidine to assure blinding.
Doses will be calculated, diluted in 50 ml of normal saline and given intravenously by a syringe pump over 10 minutes initially and then over 1 hour till the start of wound closure.
All drugs of the study will be prepared by an independent anesthesiologist who will not share in the study and then selected and given by another one blinded for the content of each syringe.
Airway devices, anesthesia machine, ventilator, flowmeters and monitors will be checked promptly.
Another wide-bore I.V cannula will be inserted in case of blood transfusion.
Monitoring equipment's (Datex-Ohmeda™) will be attached to the patient including 3-leads ECG, non-invasive arterial blood pressure, pulse oximeter and capnograph after tracheal intubation.
The depth of anesthesia will be monitored with Entropy device. The Entropy electrodes will be placed on the forehead and on the lateral angle of orbit and connected to (Datex-Ohmeda™). The target Entropy range will be 40-60 for surgical anesthesia.
Induction of anesthesia will be performed by Propofol 2 mg/kg followed by cis-atracurium 0.15 mg/kg and fentanyl 1 mcg/kg given intravenously after pre-oxygenation with 100% oxygen for at least 3 minutes.
Patients will be manually ventilated with 100% oxygen till intubation after 2 min and with Entropy value of 60 to 40 by Macintosh laryngoscope and appropriate size endotracheal tube.
Maintenance of anesthesia will be carried out by isoflurane varying its end tidal concentration to keep Entropy in the range of 55 to 40 with Air:Oxygen mixture 0.3 fraction of oxygen and flow rate of 2 liters/minute in completely closed circuit.
Cis-atracurium 0.03 mg/kg guided by neuromuscular monitor Train Of Four (TOF) will be used for muscle relaxation.
Hemodynamics (mean arterial blood pressure and heart rate) will be maintained within 25 % of baseline measures.
Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings within 2-3 min will be managed by I.V bolus of Fentanyl 0.5 mcg/kg and any decrease of MAP or HR less than 25 % on two consecutive readings within 2-3 min will be managed by I.V bolus of ephedrine 5 mg or atropine 0.5 mg respectively.
The infusion of study medication will be discontinued if the hypotension persisted > 5 minutes after these interventions upon return of the MAP or HR to within 25% of the baseline value, the study medication infusion will be resumed at 50% of the initial infusion rate and then gradually increased to the initial infusion rate.
The infusion of study medication will be discontinued at the start of wound closure. Upon completion of wound closure, isoflurane will be discontinued and the flow rate will be increased to 5 L/min of 100% Oxygen and residual neuromuscular block will be reversed with neostigmine, 0.05 mg/kg IV, and atropine 0.25 mg/kg IV. The trachea will be extubated when the patient is fully awake. Transfer to the recovery room will be done when the patient scored 7 and above using the modified Aldrete scoring system.
On emergence from anesthesia and immediately in post anesthesia care unit, analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h), will be used in all groups.
The whole technique and anesthetic procedures will be performed by the same anesthesiologist to avoid as much as possible the inter-individual skill variations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineIntervention drug of the study |
| Placebo | Placebo comparator | Drug: PlaceboNormal Saline (Placebo) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology physical status Grade I = (normal healthy patients)
- American Society of Anesthesiology physical status Grade II = (patients with mild systemic disease and no functional limitations)
- Patients scheduled for abdominal hysterectomy.
Key exclusion criteria (5 listed)
- Pre-operative regular medication with opioids and benzodiazepines, alcohol abuse, known sleep disturbance, known endocrine disease.
- Known allergy to Dexmedetomidine.
- Heart block greater than first degree.
- Medication known to affect the sympathetic response or hormonal secretion.
- Smokers
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 |
|---|---|---|
| DexmedetomidineAlso: Selective α2-agonist sympatholytic drugPatients will receive infusion of study drug intravenously 10 minutes before induction of anesthesia as 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr till the start of wound closure. | Drug | Dexmedetomidine |
| PlaceboAlso: Normal SalineFifty ml of Placebo (normal saline) will be prepared and given intravenously by a syringe pump over 10 minutes initially and then over 1 hour till the start of wound closure. | Drug | Placebo |
Primary outcome
Change in Serum Interleukin 6 (IL6)
Time frame: At starting drug infusion (10 minutes before induction of anesthesia) and then 2 hours after induction of anesthesia and 6 hours postoperatively
Measurement of Serum Serum Interleukin 6 in picogram / milliliter
10 secondary outcomes
Change in Serum Cortisol
Time frame: At starting drug infusion (10 minutes before induction of anesthesia) and then 2 hours after induction of anesthesia and 6 hours postoperatively
Change in Mean arterial blood pressure
Time frame: Mean Arterial Blood Pressure before starting infusion of the study drug, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation
Change in Heart Rate (HR)
Time frame: HR before starting infusion of the study drug, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation
Morphine Consumption in patient controlled analgesia (PCA)
Time frame: Twenty four hours after attachment of patient controlled analgesia in postoperative care unit
Fentanyl consumption in microgram using questionnaire
Time frame: During intraoperative time
Isoflurane in milliliter using the Ventilator reading
Time frame: During intraoperative time
Ephedrine in milligram using quessionnaire
Time frame: During intraoperative time
Atropine in milligram using quessionnaire
Time frame: During intraoperative time
Extubation time
Time frame: Extubation
Visual Analogue Scale VAS of Pain intensity
Time frame: VAS (visual analogue scale) at 1, 2, 4, 8, 12 and 24 hours postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed A Elsadany, MD principal investigator
Anesthesia Department, Faculty of Medicine, Suez Canal University
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Effect of Drugs, run by Suez Canal University.
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 3 inclusion and 5 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 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed A Elsadany, MD (00966541738161, sadany20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Interleukin 6 (IL6) (time frame: At starting drug infusion (10 minutes before induction of anesthesia) and then 2 hours after induction of anesthesia and 6 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2018.