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Total Intravenous AnesthesiaPhase 4NCT04048226

Dexmedetomidine-Ketamine Infusion in Breast Surgeries

A Phase 4 study testing Dexmedetomidine +Ketamine in people with Total Intravenous Anesthesia, run by Tanta 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

This is a prospective randomized double blind controlled study. Female patients undergoing radical mastectomy will be included in this study where they will be randomly allocated into; - Control group in which patients will receive continuous infusion of normal saline. Read more about this study

Who is it for?
Ages 50 to 70 years, women only
Conditions the study is for
Total Intravenous Anesthesia
What is being tested?
Dexmedetomidine +Ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
1 siteEgypt
Study dates
1 Sep 2019to 20 Mar 2024
Phase
Phase 4
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 50 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 50-70 years, ASA class I-III, and presented for elective radical mastectomy.

Who cannot join

  • Patients refused to participate.
  • Patients with known or suspected or known allergy to the used medication.
  • Patients with preoperative chronic pain,
  • Patients received preoperative opioids or gabapentoids.
  • Patients with major cardiac, renal, respiratory, or hepatic disease.
  • Uncooperative patients.
  • Obese patients with BMI >36

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta University hospitals

    Tanta, 31511

Other trials in Egypt

About this study

Official title: The Effect of Intraoperative Dexmedetomidine-Ketamine Infusion on the Patients Undergoing Radical Mastectomy: Randomized Controlled Study

  • This is a prospective randomized double blind controlled study.
  • Female patients undergoing radical mastectomy will be included in this study where they will be randomly allocated into; - Control group in which patients will receive continuous infusion of normal saline.

Dexmedetomidine-Ketamine group in which patients will receive continuous infusion of ketamine and dexmedetomidine.

The intraoperative and postoperative opioid consumption will be measured. Also, the postoperative pain score and the incidence of chronic pain will be assessed.

Read the detailed description

This prospective randomized controlled study will be carried out on 70 female patients who will be presented for radical mastectomy in the general surgery department in Tanta university hospitals over three month duration and 6 months follow up that starts immediately after obtaining ethical committee approval, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.

-Inclusion criteria: Female patients aged 50-70 years, ASA class I-III, and presented for elective radical mastectomy.

  • Exclusion criteria: Patients refused to participate. Patients with known or suspected or known allergy to the used medication. Patients with preoperative chronic pain, Patients received preoperative opioids or gabapentoids. Patients with major cardiac, renal, respiratory, or hepatic disease. Uncooperative patients. Obese patients with BMI >36

Anesthetic technique Once the patients will arrive to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached. An assistant anesthetist will help in preparation of a 50 ml syringe connected to a syringe pump that will contain normal saline or a mixture of 100 ug dexmedetomidine and 50 mg ketamine.

Anesthesia will be induced by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and cis-atracurium 0.15 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to a mechanical ventilator with its parameters adjusted to maintain etCo2 32-36 mmHg. Anesthesia will be maintained by isoflurane 1% MAC in mixture of oxygen:air 1:1 with the use of low flow (1 ml/min). The patients will be randomly allocated into two equal groups by the aid of computer-generated software of randomization: -

  • Control group (35 patients): The patients in this group will be connected to the syringe pump that contain normal saline with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery.
  • Dexmedetomidine-Ketamine group (35 patients): The patients in this group will be connected to the syringe pump that contain mixture of dexmedetomidine and ketamine with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery. The solution will contain 2 ug dexmedetomidine/ml and 1 mg ketamine/ml.

All the patients will be connected to a bispectral index monitor with maintaining its value ranging 40-60. Increase in the BIS value over 60 will be managed by additional dose of fentanyl 0.5 ug/kg till decrease the BIS below 60. If the BIS is still over 60, increasing the isoflurane 0.2 % MAC till it decreased below 60.

At the end of the surgery, switching off the inhalational anesthetics, reversal of muscle relaxation, and awake tracheal extubation will be done with transporting the patients to the PACU for postoperative follow up and monitoring.

  • Measurements:
  1. Patient age, weight, height.
  2. Morphine consumption in the first 24 h postoperatively.
  3. The total dose consumption of fentanyl consumed intraoperatively.
  4. The total volume consumed of isoflurane intraoperatively (ml/hr).
  5. The postoperative Visual Analogue Score (VAS): It will be measured every 2 hours till 8 h, then every 4 h till 24 h. In case of increase the VAS more than 3, a rescue analgesia will be administrated in the form of 3 mg morphine i.v that may be repeated.
  6. The time for the first request of morphine rescue analgesia
  7. The incidence of chronic pain (Follow up of the patients will be carried out in the pain clinic after discharge from hospital every 2 weeks for a period of 6 months for assessment of the incidence of postoperative chronic pain.
  8. The recovery profile
  9. The incidence of complications
Being tested
Placebos, Dexmedetomidine +Ketamine
Keywords
Dexmedetomidine, Ketamine, Radical Mastectomy, Chronic pain
Medical subject headings
Chronic Pain

What participants receive

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

  • PlacebosDrug

    Also called Normal saline infusion

    The patients in this group will be connected to the syringe pump that contain normal saline with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery.

  • Dexmedetomidine +KetamineDrug

    Also called Intravenous anesthesia

    The patients in this group will be connected to the syringe pump that contain mixture of dexmedetomidine and ketamine with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery. The solution will contain 2 ug dexmedetomidine/ml and 1 mg ketamine/ml.

Study groups in NCT04048226
Study groupRoleWhat they receive
Control groupPlacebo comparatorThe patients in this group will be connected to the syringe pump that contain normal saline with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery.
Receives: Drug: Placebos
Dexmedetomidine-Ketamine groupExperimentalThe patients in this group will be connected to the syringe pump that contain mixture of dexmedetomidine and ketamine with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery. The solution will contain 2 ug dexmedetomidine/ml and 1 mg ketamine/ml.
Receives: Drug: Dexmedetomidine +Ketamine

What is being measured

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

  1. The postoperative morphine consumption

    The total dose of morphine consumed postoperative as a rescue analgesia to maintain the VAS less than 4

    Measured: The first 24 hours postoperatively

Secondary outcomes (2)
  1. The intraoperative fentanyl consumption

    The intraoperative consumption of fentanyl

    Measured: Through out the whole intraoperative period

  2. Incidence of the chronic pain

    The patients who suffer from chronic pain during 6 months of follow up using simple questionnaire

    Measured: 6 months after the surgery

Timeline

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

  1. First posted7 Aug 2019
  2. Study start1 Sep 2019
  3. Primary completion20 Mar 2024
  4. Study completion20 Mar 2024

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 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized controlled study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04048226
Sponsor's protocol ID
33108/05/19
Other IDs
Tanta University
Status last verified
Apr 2024
First submitted
6 Aug 2019
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Once the study had been successfully completed, the data will be shared for other researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine +Ketamine in people with Total Intravenous Anesthesia, run by Tanta 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 30 Apr 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The postoperative morphine consumption (time frame: The first 24 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 30 Apr 2024.

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