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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Faculty of Medicine, Cairo University

    Cairo

Other trials in Egypt

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)

  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

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.

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 groups in NCT05226325
Study groupRoleWhat they receive
G0.2Active 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
G0.4Active 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
G0.6Active 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.

  1. Surgical field quality using Fromme et al 6-point bleeding scale

    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

    Measured: Through operative time, an average of 1 to 2 hours

Secondary outcomes (8)
  1. Intraoperative hemodynamics including MAP (mmHg)

    MAP: Mean arterial pressure HR: Heart rate

    Measured: Through operative time, an average of 1 to 2 hours

  2. Intraoperative hemodynamics including HR ( beats/min.)

    HR: Heart Rate

    Measured: Through operative time, an average of 1 to 2 hours

  3. 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

  4. 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

  5. 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

  6. 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

  7. Postoperative Sedation Score

    Sedation Score: Ramesy Sedation Scale

    1. Patient is anxious and agitated or restless, or both
    2. Patient is co-operative, oriented, and tranquil
    3. Patient responds to commands only
    4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
    5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
    6. Patient exhibits no response

    Measured: Two hours

  8. 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.

  1. First posted7 Feb 2022
  2. Study start15 Feb 2022
  3. Primary completion25 Jul 2022
  4. Study completion2 Aug 2022

Resources

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)
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

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.

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