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Dexmedetomidine-Ketamine Infusion in Breast Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04048226
Recruitment Status : Completed
First Posted : August 7, 2019
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Sameh Abdelkhalik Ahmed Ismaiel, Tanta University

Tracking Information
First Submitted Date  ICMJE August 6, 2019
First Posted Date  ICMJE August 7, 2019
Last Update Posted Date August 19, 2020
Actual Study Start Date  ICMJE September 1, 2019
Actual Primary Completion Date August 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
The postoperative morphine consumption [ Time Frame: The first 24 hours postoperatively ]
The total dose of morphine consumed postoperative as a rescue analgesia to maintain the VAS less than 4
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • The intraoperative isoflurane consumption [ Time Frame: Through out the whole intraoperative period ]
    The intraoperative consumption of isoflurane in ml per one hour
  • Incidence of the chronic pain [ Time Frame: 6 months after the surgery ]
    The patients who suffer from chronic pain during 6 months of follow up using simple questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • The intraoperative isoflurane consumption [ Time Frame: Through out the whole intraoperative period ]
    The intraoperative consumption of isoflurane in ml per one hour
  • Incidence of the chronic pain [ Time Frame: 6 months after the surgery ]
    The patients who suffer from chronic pain during 6 months of follow up
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine-Ketamine Infusion in Breast Surgeries
Official Title  ICMJE The Effect of Intraoperative Dexmedetomidine-Ketamine Infusion on the Patients Undergoing Radical Mastectomy: Randomized Controlled Study
Brief Summary
  • This is a prospective randomized double blind controlled study.
  • Female patients undergoing radical mastectomy will be included in this stydy where they will be randomly allocated into;- Control group in which patients will receive continuous infusion of normal saline.

Dexmedetomidine-Ketamine group 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.

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-II, 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 (30 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 1ug/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 intraopeartively.
  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 6 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective randomized controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
  • The patients will be blind through the use of closed sealed envelops.
  • The investigator will be blind through the use of syringe pump containing normal saline in the control group by the aid of anesthesia resident who will not participate in the study.
  • The measurement will be collected by anesthesia nurse not participating in the study and blinded to its group.
Primary Purpose: Supportive Care
Condition  ICMJE Total Intravenous Anesthesia
Intervention  ICMJE
  • Drug: Placebos
    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.
    Other Name: Normal saline infusion
  • Drug: Dexmedetomidine +Ketamine
    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.
    Other Name: Intravenous anesthesia
Study Arms  ICMJE
  • Placebo Comparator: Control group
    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.
    Intervention: Drug: Placebos
  • Experimental: Dexmedetomidine-Ketamine group
    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.
    Intervention: Drug: Dexmedetomidine +Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2020)
98
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2019)
100
Actual Study Completion Date  ICMJE August 14, 2020
Actual Primary Completion Date August 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patients aged 50-70 years, ASA class I-II, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Participant eligibility is not based on self-representation of gender identity.
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04048226
Other Study ID Numbers  ICMJE 33108/05/19
Tanta University ( Other Identifier: Faculty of Medicine, Tanta University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Once the study had been successfully completed, the data will be shared for other researchers.
Responsible Party Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
Study Sponsor  ICMJE Tanta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sameh Ismaiel, M.D Lecturer of Anesthesia and Intensive Care, Tanta University
PRS Account Tanta University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP