Pain ManagementNCT05226325
Dexmedetomidine Different Doses as Adjuvant to Entropy-assisted General Anesthesia During Functional Endoscopy Sinus Surgery.
A study testing Dexmedetomidine in people with Pain Management and Dexmedetomidine, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of work to assess the effect of different doses of Dexmedetomidine when used as an adjuvant to entropy-guided general anesthesia on the intraoperative surgical field quality, inhaled anesthesia consumption and postoperative analgesia requirement during FESS surgeries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain Management, Dexmedetomidine, Anesthesia
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2022to 2 Aug 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiology (ASA) Class I or II undergoing elective functional endoscopic sinus surgery.
Who cannot join
- American Society of Anaesthesiology (ASA) Class ≥ III
- Allergy or hypersensitivity to Dexamedetomidine.
- History of myocardial dysfunction.
- Cardiac dysrhythmia and Heart block
- Patients receiving beta blockers or calcium channel blockers
- Patient refusal
- Patient with known history of hepatic or renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Different Doses as Adjuvant to Entropy-assisted General Anesthesia During Functional Endoscopy Sinus Surgery. A Randomized Comparative Study
The aim of work to assess the effect of different doses of Dexmedetomidine when used as an adjuvant to entropy-guided general anesthesia on the intraoperative surgical field quality, inhaled anesthesia consumption and postoperative analgesia requirement during FESS surgeries.
Read the detailed description
This randomized comparative study is designed to:
- To assess between the effect of different dose Dexmedetomidine infusions on the surgical field quality.
- To determine the effect of different dose of Dexmedetomidine infusions on the required MAC of isoflurane needed to maintain entropy between 40-60.
- To determine the effect of different of Dexmedetomidine on the patient recovery time, and the postoperative analgesic requirement.
Hypothesis
The primary objective of this study is to find out the optimum infusion dose of Dexmedetomidine for the best surgical field quality, reduces inhalational anesthetic requirement without affecting recovery time.
On arrival to the operating room, an 18G cannula will be inserted and 500 ml Ringer acetate solution will be started slowly. Standard monitoring (electrocardiography, pulse oximetry and non-invasive blood pressure monitoring) will be connected to the patient, baseline blood pressure and heart rate will be measured and recorded. The 3-electrode sensor of the entropy (GE carestation 650) will be applied to the patient's forehead and the baseline state entropy (SE) and response entropy (RE) will be recorded. The patient will be premedicated with intravenous Ranitidine 50 mg and Metoclopramide 10 mg. Patients will be equally divided into three equal groups and will be given the following according to group allotted.
G0.2: (33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.2 mcg/kg/hour G0.4: (33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.4 mcg/kg/hour G0.6: (33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.6 mcg/kg/hour
Induction of general anesthesia will be carried out using fentanyl 2mcg/kg Propofol 1.5-2 ml/kg and endotracheal intubation will be facilitated with Atracurium 0.5mg/kg.
General anesthesia will be maintained using isoflurane, the vol % will be adjusted at 1.2% to 2% to maintain a target entropy 40-60. The repeated doses of Atracurium 0.1 mg/kg every 20-30 minutes will be administered guided by peripheral nerve stimulator.
Hemodynamics including mean arterial blood pressure and heart rate along with entropy will be recorded every 5 minutes for the first 20 minutes after induction of GA and every 15 minutes till the end of surgery. Bradycardia (Heart rate < 50 beat/min) will be treated with atropine 0.02 mg/kg. Hypotension (MAP < 55 mmHg) will be treated with fluids and Ephedrine 5mg iv. All surgeries will be accomplished by the same surgeon using the same surgical technique. The surgical field quality will be rated by the surgeon once the surgery started and every 30 minutes using a 6-point scale for evaluation of operative field visibility (Boezaart Surgical Field Grading Scale).
Grade Assessment 0 No bleeding (cadaveric conditions)
- Slight bleeding - no suctioning required
- Slight bleeding - occasional suctioning required
- Slight bleeding - frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed
- Moderate bleeding - frequent suctioning required and bleeding threatens surgical field directly after suction is removed
- Severe bleeding - constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely compromised
The lowest isoflurane vol % needed to keep a target of 40-60 reading on entropy recorded on the same time table used for the vital signs measured throughout the study. 1 gm of paracetamol will be give intra-venous at the end of surgery.The residual effect of the muscle relaxant will be reversed with administration of neostigmine 0.05 mg/kg and atropine 0.02 mg/kg once TOF count is 2/4. When the patients is able to obey verbal commands, endotracheal tube will be removed after suctioning the airway under direct vision, the patient will then moved to the Post Anesthesia Care Unit (PACU). The recovery time (between stopping of inhalational anesthesia till time of patient obeying) and the duration of Anesthesia defined as time interval between induction of Anesthesia and endotracheal extubation will both calculated and recorded.
Upon arrival to PACU, patients will be monitored with non-invasive blood pressure and pulse oximeter. Oxygen masks will placed on the patients with a flow rate of 6 L/min. The pain will be assessed using the visual analogue scale, and sedation will be assessed using the Ramsay sedation scale every thirty-minutes for two hours. Rescue analgesia will be provided with Pethidine 0.5mg/kg intravenously for those who complained of pain or with VAS score greater than 3.
After two hours, patients that have a score of nine or more on the modified Aldrete discharge scoring system will be discharged to the ward.
- Conditions
- Pain Management, Dexmedetomidine, Anesthesia
- Being tested
- Dexmedetomidine
- Keywords
- Entropy, FESS
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minute followed by infusion
| Study group | Role | What they receive |
|---|---|---|
| G0.2 | Active comparator | (33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.2 mcg/kg/hour Receives: Drug: Dexmedetomidine |
| G0.4 | Active comparator | (33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.4 mcg/kg/hour Receives: Drug: Dexmedetomidine |
| G0.6 | Active comparator | (33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.6 mcg/kg/hour Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical field quality using Fromme et al 6-point bleeding scale
0 No bleeding (cadaveric conditions)
- Slight bleeding - no suctioning required
- Slight bleeding - occasional suctioning required
- Slight bleeding - frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed
- Moderate bleeding - frequent suctioning required and bleeding threatens surgical field directly after suction is removed
- Severe bleeding - constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely compromised
Measured: Through operative time, an average of 1 to 2 hours
Secondary outcomes (8)
Intraoperative hemodynamics including MAP (mmHg)
MAP: Mean arterial pressure HR: Heart rate
Measured: Through operative time, an average of 1 to 2 hours
Intraoperative hemodynamics including HR ( beats/min.)
HR: Heart Rate
Measured: Through operative time, an average of 1 to 2 hours
End tidal isoflurane concentration needed to maintain SE 40-60
SE: State Entropy
Entropy is a quantitative EEG device which captures a single-lead frontal EEG via a 3-electrode sensor applied to the patient's forehead. The state entropy (SE) scale ranges from 0 (no brain activity) to 91 (fully awake)
Measured: Through operative time, an average of 1 to 2 hours
End tidal isoflurane concentration needed to maintain RE 40-60
RE: Response Entropy
Entropy is a quantitative EEG device which captures a single-lead frontal EEG via a 3-electrode sensor applied to the patient's forehead. The response entropy (RE) scale ranges from 0 (no brain activity) to 100 (fully awake).
Measured: Through operative time, an average of 1 to 2 hours
The duration of anesthesia and recovery time
Duration of Anesthesia: Time interval between induction if Anesthesia and endotracheal extubation.
The recovery time: Time interval between discontinuation of the inhalational anesthesia and extubation of endotracheal tube.
Measured: Through operative and recovery time, an average of 3 to 4 hours
Postoperative Pain Score
Pain Score: Visual analog scale subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: Two hours
Postoperative Sedation Score
Sedation Score: Ramesy Sedation Scale
- Patient is anxious and agitated or restless, or both
- Patient is co-operative, oriented, and tranquil
- Patient responds to commands only
- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
- Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
- Patient exhibits no response
Measured: Two hours
Immediate postoperative pethidine consumption (mg) in PACU
PACU: Poat Anesthesia Care Unit
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start15 Feb 2022
- Primary completion25 Jul 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Youssef Ollaek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226325
- Sponsor's protocol ID
- ms-393-2020
- Status last verified
- Nov 2022
- First submitted
- 6 Jan 2022
- Last updated
- 10 Nov 2022
- 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 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Different Doses as Adjuvant to Entropy-assisted General Anesthesia During Functional Endoscopy Sinus Surgery. A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05226325
- Acronym / sponsor ID
- ms-393-2020
- Conditions
- Pain Management, Dexmedetomidine, Anesthesia
- Keywords
- Entropy, FESS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 7 Feb 2022 (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 work to assess the effect of different doses of Dexmedetomidine when used as an adjuvant to entropy-guided general anesthesia on the intraoperative surgical field quality, inhaled anesthesia consumption and postoperative analgesia requirement during FESS surgeries.
Detailed description
This randomized comparative study is designed to:
- To assess between the effect of different dose Dexmedetomidine infusions on the surgical field quality.
- To determine the effect of different dose of Dexmedetomidine infusions on the required MAC of isoflurane needed to maintain entropy between 40-60.
- To determine the effect of different of Dexmedetomidine on the patient recovery time, and the postoperative analgesic requirement.
Hypothesis
The primary objective of this study is to find out the optimum infusion dose of Dexmedetomidine for the best surgical field quality, reduces inhalational anesthetic requirement without affecting recovery time.
On arrival to the operating room, an 18G cannula will be inserted and 500 ml Ringer acetate solution will be started slowly. Standard monitoring (electrocardiography, pulse oximetry and non-invasive blood pressure monitoring) will be connected to the patient, baseline blood pressure and heart rate will be measured and recorded. The 3-electrode sensor of the entropy (GE carestation 650) will be applied to the patient's forehead and the baseline state entropy (SE) and response entropy (RE) will be recorded. The patient will be premedicated with intravenous Ranitidine 50 mg and Metoclopramide 10 mg. Patients will be equally divided into three equal groups and will be given the following according to group allotted.
G0.2: (33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.2 mcg/kg/hour G0.4: (33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.4 mcg/kg/hour G0.6: (33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.6 mcg/kg/hour
Induction of general anesthesia will be carried out using fentanyl 2mcg/kg Propofol 1.5-2 ml/kg and endotracheal intubation will be facilitated with Atracurium 0.5mg/kg.
General anesthesia will be maintained using isoflurane, the vol % will be adjusted at 1.2% to 2% to maintain a target entropy 40-60. The repeated doses of Atracurium 0.1 mg/kg every 20-30 minutes will be administered guided by peripheral nerve stimulator.
Hemodynamics including mean arterial blood pressure and heart rate along with entropy will be recorded every 5 minutes for the first 20 minutes after induction of GA and every 15 minutes till the end of surgery. Bradycardia (Heart rate < 50 beat/min) will be treated with atropine 0.02 mg/kg. Hypotension (MAP < 55 mmHg) will be treated with fluids and Ephedrine 5mg iv. All surgeries will be accomplished by the same surgeon using the same surgical technique. The surgical field quality will be rated by the surgeon once the surgery started and every 30 minutes using a 6-point scale for evaluation of operative field visibility (Boezaart Surgical Field Grading Scale).
Grade Assessment 0 No bleeding (cadaveric conditions)
- Slight bleeding - no suctioning required
- Slight bleeding - occasional suctioning required
- Slight bleeding - frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed
- Moderate bleeding - frequent suctioning required and bleeding threatens surgical field directly after suction is removed
- Severe bleeding - constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely compromised
The lowest isoflurane vol % needed to keep a target of 40-60 reading on entropy recorded on the same time table used for the vital signs measured throughout the study. 1 gm of paracetamol will be give intra-venous at the end of surgery.The residual effect of the muscle relaxant will be reversed with administration of neostigmine 0.05 mg/kg and atropine 0.02 mg/kg once TOF count is 2/4. When the patients is able to obey verbal commands, endotracheal tube will be removed after suctioning the airway under direct vision, the patient will then moved to the Post Anesthesia Care Unit (PACU). The recovery time (between stopping of inhalational anesthesia till time of patient obeying) and the duration of Anesthesia defined as time interval between induction of Anesthesia and endotracheal extubation will both calculated and recorded.
Upon arrival to PACU, patients will be monitored with non-invasive blood pressure and pulse oximeter. Oxygen masks will placed on the patients with a flow rate of 6 L/min. The pain will be assessed using the visual analogue scale, and sedation will be assessed using the Ramsay sedation scale every thirty-minutes for two hours. Rescue analgesia will be provided with Pethidine 0.5mg/kg intravenously for those who complained of pain or with VAS score greater than 3.
After two hours, patients that have a score of nine or more on the modified Aldrete discharge scoring system will be discharged to the ward.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G0.2 | Active comparator | Drug: Dexmedetomidine(33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.2 mcg/kg/hour |
| G0.4 | Active comparator | Drug: Dexmedetomidine(33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.4 mcg/kg/hour |
| G0.6 | Active comparator | Drug: Dexmedetomidine(33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.6 mcg/kg/hour |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiology (ASA) Class I or II undergoing elective functional endoscopic sinus surgery.
Key exclusion criteria (7 listed)
- American Society of Anaesthesiology (ASA) Class ≥ III
- Allergy or hypersensitivity to Dexamedetomidine.
- History of myocardial dysfunction.
- Cardiac dysrhythmia and Heart block
- Patients receiving beta blockers or calcium channel blockers
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 |
|---|---|---|
| Dexmedetomidinepatients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minute followed by infusion | Drug | G0.2, G0.4, G0.6 |
Primary outcome
Surgical field quality using Fromme et al 6-point bleeding scale
Time frame: Through operative time, an average of 1 to 2 hours
0 No bleeding (cadaveric conditions) 1. Slight bleeding - no suctioning required 2. Slight bleeding - occasional suctioning required 3. Slight bleeding - frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed 4. Moderate bleeding - frequent suctioning required and bleeding threatens surgical field directly after suction is removed 5. Severe bleeding - constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely compromised
8 secondary outcomes
Intraoperative hemodynamics including MAP (mmHg)
Time frame: Through operative time, an average of 1 to 2 hours
Intraoperative hemodynamics including HR ( beats/min.)
Time frame: Through operative time, an average of 1 to 2 hours
End tidal isoflurane concentration needed to maintain SE 40-60
Time frame: Through operative time, an average of 1 to 2 hours
End tidal isoflurane concentration needed to maintain RE 40-60
Time frame: Through operative time, an average of 1 to 2 hours
The duration of anesthesia and recovery time
Time frame: Through operative and recovery time, an average of 3 to 4 hours
Postoperative Pain Score
Time frame: Two hours
Postoperative Sedation Score
Time frame: Two hours
Immediate postoperative pethidine consumption (mg) in PACU
Time frame: Two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Pain Management and Dexmedetomidine, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 10 Nov 2022. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical field quality using Fromme et al 6-point bleeding scale (time frame: Through operative time, an average of 1 to 2 hours). 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 10 Nov 2022.