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AnesthesiaNCT02652312

Dexmedetomidine and Desflurane Consumption

A study testing Dexmedetomidine, Ondansetron and fentanyl in people with Anesthesia, run by Theodor Bilharz Research Institute 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 this study is to calculate desflurane consumption when combined with intraoperative dexmedetomidine infusion guided by bispectral index (BIS) Read more about this study

Who is it for?
Ages 15 to 50 years
Conditions the study is for
Anesthesia
What is being tested?
Dexmedetomidine, Ondansetron and fentanyl
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteEgypt
Study dates
Feb 2016to Oct 2016
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 15 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) status of I and II
  • undergoing elective laparoscopic cholecystectomy

Who cannot join

  • history of psychiatric/neurological illness
  • cardiovascular disease
  • morbid obese patients
  • pregnant and nursing women
  • known allergic reaction to any of the study medication
  • recent use of sedatives or analgesics

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Theodor Bilharz Research Institute

    Giza, 12411

Other trials in Egypt

About this study

Official title: Effect of Dexmedetomidine Infusion on Desflurane Consumption and Hemodynamics During BIS Guided Laparoscopic Surgery: A Randomized Controlled Study

The aim of this study is to calculate desflurane consumption when combined with intraoperative dexmedetomidine infusion guided by bispectral index (BIS)

Read the detailed description

Forty patients will be randomly allocated into two equal groups as Group 'D' (Dexmedetomidine group) and Group 'P' (Placebo group) using computer generated random numbers. After arrival in the operating room, ondansetron 0.15 mg/kg intravenous (IV) will be given as a pre-medication. Ringer's acetate solution (500 ml) will be infused as a preload then at a rate of 6-8 ml/kg/h during surgery for supplying maintenance and deficit. Monitoring consisted of continuous electrocardiogram (EKG), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), CO2 expired fraction (ETCO2), desflurane inspired fraction (FIdes), and desflurane expired fraction (ETdes) (Infinity Kappa, Dräger, Lübeck, Germany) will be attached to the patient. BIS module (InfinityR BISxTM SmartPodR, smoothing rate: 15 or 30 seconds, software revision: VF5) will also be attached for detection of consciousness level.

All patients will be preoxygenated with 100% oxygen for 3 minutes. The patients in group D will receive dexmedetomidine (2 ml diluted in 18 ml of saline) IV in a dose of 1 mcg/kg over10 minutes through infusion pump prior to induction. Group P patients will receive similar volume of normal saline over 10 min. The study drug and placebo infusions will be prepared by an anesthesiologist who is not involved in the study and the anesthesiologist recording the details is unaware of the type of infusion patients received. Anesthesia will be induced with IV fentanyl 1.5 μg/kg and propofol in a dose of 10 mg every 5 seconds until the BIS level dropped below 60 and confirmed with loss of response to verbal commands. In both groups, Atracurium 0.5 mg/kg IV will be administered, and trachea will be intubated. Fresh gas flow oxygen in air 30-40% at a rate of 3 L/min for 10 minutes will be administered then the flow will be decreased at a rate of 1 L/min using a closed system (Fabius GS, Dräger, Lübeck, Germany) and ventilation will be adjusted to maintain end-tidal carbon dioxide at 30-35 mmHg. Patients in study groups will receive the volatile agent at a concentration of 1 MAC (Minimum Alveolar Concentration). The MAC of desflurane is defined as an expired fraction of 6.0 vol%. Then the dial-up desflurane percentage will be adjusted to establish a BIS value between 40- 50. A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour made to 20 mL with normal saline will be administered in group D patients and a similar volume of normal saline will be administered in Group P, till the end of surgery. Top up doses of Atracurium will be given as needed. When heart rate and blood pressure exceeds 20% of baseline in spite of adequate level of anesthesia guided by BIS, boluses of 0.5 μg/kg will be given. While decrease in heart rate and blood pressure more than 20% of baseline, will be treated by ephedrine 5 mg.

In both groups, dexmedetomidine or saline will be stopped approximately 15-20 minutes before completion of surgery, diclofenac sodium 1 mg/kg will be given IM at the time of skin closure. Desflurane will be discontinued after skin closure in both groups. Reversal of neuromuscular blockade will be achieved with neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Tracheal extubation will be done when respiration is satisfactory and adequate muscle tone is achieved

Conditions
Anesthesia
Keywords
Dexmedetomidine, Desflurane, Bispectral Index BIS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Precedex, Dexdor

    A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour made to 20 mL with normal saline will be administered

  • PlaceboDrug

    Also called placebo effect

    A maintenance dose of 20 mL with normal saline will be administered at a rate similar to that of dexmedetomidine

  • OndansetronProcedure or surgery

    Also called Zofran

    0.15 mg/kg intravenous (IV) will be given as a pre-medication

  • fentanylProcedure or surgery

    Also called Sublimaze,Actiq, Durogesic, Duragesic

    1.5 μg/kg intraoperative

  • propofolProcedure or surgery

    Also called Diprivan

    10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia

  • AtracuriumProcedure or surgery

    Also called Atracurium besilate

    0.5 mg/kg IV for endotracheal intubation

  • diclofenac sodiumProcedure or surgery

    Also called Voltaren

    1 mg/kg for postoperative analgesia

  • desfluraneProcedure or surgery

    Also called Suprane

    1 MAC concentration (expired fraction of 6.0 vol%) for maintenance of anesthesia

Study groups in NCT02652312
Study groupRoleWhat they receive
Group 'D'Active comparatorDexmedetomidine group Patients received dexmedetomidine (2 ml diluted in 18 ml of saline) IV in a dose of 1 mcg/kg over 10 minutes. A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour was infused. Ondansetron: 0.15 mg/kg intravenous preoperative. Fentanyl: 1.5 μg/kg intraoperative Propofol: 10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia. Atracurium: 0.5 mg/kg IV. Desflurane: 1 MAC concentration. Diclofenac sodium: 1 mg/kg for postoperative analgesia.
Receives: Drug: Dexmedetomidine; Procedure: Ondansetron; Procedure: fentanyl; Procedure: propofol; Procedure: Atracurium; Procedure: diclofenac sodium; Procedure: desflurane
Group 'P'Placebo comparatorPlacebo group Patients received similar volume of normal saline as the bolus and maintenance infusion as group D. Ondansetron: 0.15 mg/kg intravenous preoperative. Fentanyl: 1.5 μg/kg intraoperative Propofol: 10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia. Atracurium: 0.5 mg/kg IV. Desflurane: 1 MAC concentration. Diclofenac sodium: 1 mg/kg for postoperative analgesia.
Receives: Drug: Placebo; Procedure: Ondansetron; Procedure: fentanyl; Procedure: propofol; Procedure: Atracurium; Procedure: diclofenac sodium; Procedure: desflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. desflurane consumption (ml)

    Calculation of desflurane consumption during the intraoperative period

    Measured: Intraoperative

Secondary outcomes (3)
  1. Heart Rate (Beat/min)

    Recording of the heart rate during the intraoperative period before induction, after induction, after intubation, and then at 5, 10, 15, 30, 45, and 60 minute after intubation and at extubation.

    Measured: Intraoperative

  2. Blood Pressure (mm Hg)

    Recording of the heart rate during the intraoperative period before induction, after induction, after intubation, and then at 5, 10, 15, 30, 45, and 60 minute after intubation and at extubation.

    Measured: Intraoperative

  3. Fentanyl consumption (ug)

    Total intraoperative fentanyl consumption

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionOct 2016
  4. Study completionOct 2016

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02652312
Sponsor's protocol ID
Anesthesia 110T
Status last verified
Nov 2016
First submitted
6 Jan 2016
Last updated
10 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Harsoor SS, Rani DD, Lathashree S, Nethra SS, Sudheesh K. Effect of intraoperative Dexmedetomidine infusion on Sevoflurane requirement and blood glucose levels during entropy-guided general anesthesia. J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):25-30. doi: 10.4103/0970-9185.125693.

    PubMed 24574589
  • Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. doi: 10.1097/00000542-200011000-00030. No abstract available.

    PubMed 11046225
  • Nishibe S, Imanishi H, Mieda T, Tsujita M. The effects of dexmedetomidine administration on the pulmonary artery pressure and the transpulmonary pressure gradient after the bidirectional superior cavopulmonary shunt. Pediatr Cardiol. 2015 Jan;36(1):151-7. doi: 10.1007/s00246-014-0979-2. Epub 2014 Aug 12.

    PubMed 25113519

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine, Ondansetron and fentanyl in people with Anesthesia, run by Theodor Bilharz Research Institute 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 2 inclusion and 6 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 2016. 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. 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?

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?

desflurane consumption (ml) (time frame: Intraoperative). 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 NCT02652312, which also lists 3 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 10 Nov 2016.

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Dexmedetomidine and Desflurane Consumption | AzTrials