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Intrathecal Ketamine, Dexmedetomidine and Both With Bupivacaine for Postoperative Abdominal Cancer Surgery Pain

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ClinicalTrials.gov Identifier: NCT02455609
Recruitment Status : Unknown
Verified May 2015 by Ahmad Mohammad Abd El-Rahman, Assiut University.
Recruitment status was:  Active, not recruiting
First Posted : May 28, 2015
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Ahmad Mohammad Abd El-Rahman, Assiut University

Tracking Information
First Submitted Date  ICMJE May 18, 2015
First Posted Date  ICMJE May 28, 2015
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
Visual Analogue Scale (VAS) [ Time Frame: the first 24 hours postoperative ]
efficacy of analgesia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • time to first request of analgesia [ Time Frame: the first 24 hours postoperative ]
    time needed by participating patients in each group to ask for rescue analgesia during the first 24 hours postoperative
  • total analgesic consumption [ Time Frame: the first 24 hours postoperative ]
    total amount of rescue analgesic taken by patients in each group during the first 24 hours postoperative
  • side effects [ Time Frame: the first 24 hours postoperative ]
    incidence of nausea (no.), vomiting (no.), hypotension (mmHg), bradycardia (b/m), hypertension (mmHg), arrhythmia (no.), sedation (by a 0-4 sedation scale) experienced by participating patients in each group
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrathecal Ketamine, Dexmedetomidine and Both With Bupivacaine for Postoperative Abdominal Cancer Surgery Pain
Official Title  ICMJE Intrathecally Administered Ketamine, Dexmedetomidine, and Their Combination With Bupivacaine for Postoperative Analgesia in Major Abdominal Cancer Surgery
Brief Summary Currently, opioids are widely used for pain relief, but they often provide sub-optimal analgesia with occasional serious side effects. Preservative-free ketamine hydrochloride was introduced as a spinal anesthetic more than twenty years ago and found to have advantages over local anesthetics. Intrathecal dexmedetomidine provides an analgesic effect in postoperative pain without severe sedation. The objectives of this study were to compare the efficacy and safety of intrathecally administered dexmedetomidine, ketamine, or their combination when added to bupivacaine for postoperative analgesia in major abdominal cancer surgery.
Detailed Description

This study was approved by the ethics committee of South Egypt Cancer Institute, Assiut University, Assiut, Egypt. After obtaining a written informed consent, 90 American Society of Anesthesia (ASA) I-II patients aged 30-50 years and scheduled for major abdominal cancer surgery were included in the study. Patients with a known allergy to the study drugs, significant cardiac, respiratory, renal or hepatic disease, coagulation disorder, infection at the site of intrathecal injection, drug or alcohol abuse, BMI > 30 kg/m2 , and psychiatric illnesses that would interfere with perception and assessment of pain were excluded from the study.

Preoperatively, patients were taught how to evaluate their own pain intensity using the visual analogue scale (VAS), scored from 0 -10 (where 0 = no pain, and 10 = the worst pain imaginable).

Oral diazepam (5 mg) was taken the night before surgery. Up on arrival at the operative theatre, a 16-gauge catheter was introduced intravenously at the dorsum of the hand; lactated Ringer's solution 10 mg/kg was infused intravenously over 10 min. before initiation of spinal anesthesia. Basic monitoring probes (electrocardiography, non invasive blood pressure, O2 saturation, and temperature) were applied. Patients were placed in the setting position and a 25-gauge Quincke needle was placed in the L2-3 or L3-4 interspaces.

Patients were randomly divided, by selecting sealed envelopes into one of three groups 30 patients each:

  • The dexmedetomidine group (group I) received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine in 1 ml volume intrathecally.
  • The ketamine group (group II) received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally.
  • Dexmedetomidine + Ketamine group (group III) received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine plus 0.1 mg/kg of Ketamine in 1 ml volume intrathecally.

Immediately after their intrathecal injection, the patients were placed in the supine position. After successful spinal anesthesia, general anesthesia was induced with fentanyl 1.5-2 µg/kg, propofol 2-3 mg/kg, and lidocaine 1.5 mg/kg. Endotracheal intubation was facilitated by cis-atracurium 0.15 mg/kg. Heart rate, systolic, and diastolic blood pressure were recorded at 5, 10, 20, 30, 60, 120, 180 minutes. Anesthesia and muscle relaxation were maintained by isoflurane 1- 1.5 MAC in 50% oxygen/air mixture and cis-atracurium 0.03 mg/kg bolus given every 30 min. respectively.

At the end of surgery, muscle relaxation was reversed by neostigmine 50 µg/kg and atropine 20 µg/kg. Patients were extubated and transferred to postanesthesia care unit (PACU) and were monitored for vital signs (heart rate, non invasive blood pressure, respiratory rate, and O2 saturation) immediately postoperative and at 2, 4, 6, 12, 18, and 24 hours postoperative.

VAS scores were assessed at the same time points. Rescue analgesia represented by patient-controlled analgesia (PCA) with intravenous morphine with an initial bolus of 0.1 mg/kg once pain was expressed by the patient, or if VAS was 3 or more (VAS ≥ 3) followed by 1 mg boluses with a lockout period of 5 min. The time of first request of analgesia and total analgesic consumption in the first 24 hours postoperatively were recorded.

The patient's level of sedation was assessed at the same time points using a modified Observer's Assessment of alertness/sedation (OAAS) scale (where 6 = agitated, and 0 = doesn't respond to deep stimuls).

The attendant anesthesiologist, the patient-care giver, and the data collection personnel were all blinded to patient assignment to a specific group. Postoperative adverse effects such as nausea, vomiting, hypotension, bradycardia, cardiac arrhythmias were recorded and treated.

Hypotension was defined as a 15% decrease in systolic blood pressure from baseline. Bradycardia was defined as a heart rate slower than 50 beats per minute or a decrease in heart rate of 20% or more from baseline; whichever is lowest. Hypoxia was defined as an oxygen saturation of less than 90%. Hypotension was treated with intravenous boluse of ephidrine 0.1 mg/kg and normal saline 5ml/kg; the same doses were repeated as required. Bradycardia was treated with intravenous atropine 0.01 mg/kg.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Therapy
  • Pain Management
Intervention  ICMJE
  • Procedure: intrathecal drug administration
    pre-emptive intrathecal administration of analgesic medications for control of postoperative pain.
  • Drug: Dexmedetomidine
  • Drug: ketamine
  • Drug: Bupivacaine
Study Arms  ICMJE
  • Active Comparator: dexmedetomidine (I)
    intrathecal drug administartion of 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine in 1 ml volume.
    Interventions:
    • Procedure: intrathecal drug administration
    • Drug: Dexmedetomidine
    • Drug: Bupivacaine
  • Active Comparator: ketamine (II)
    intrathecal drug administartion of 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume.
    Interventions:
    • Procedure: intrathecal drug administration
    • Drug: ketamine
    • Drug: Bupivacaine
  • Active Comparator: Dexmedetomidine + Ketamine group (III)
    intrathecal drug administartion of patients in this arm received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 5µg of dexmedetomidine plus 0.1 mg/kg of Ketamine in 1 ml volume.
    Interventions:
    • Procedure: intrathecal drug administration
    • Drug: Dexmedetomidine
    • Drug: ketamine
    • Drug: Bupivacaine
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 27, 2015)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 30-50 years
  • American Society of Anesthesia (ASA) I-II patients
  • scheduled for major abdominal cancer surgery

Exclusion Criteria:

  • known allergy to the study drugs.
  • significant cardiac, respiratory, renal or hepatic disease
  • coagulation disorder
  • infection at the site of intrathecal injection
  • drug or alcohol abuse
  • BMI > 30 kg/m2
  • psychiatric illnesses that would interfere with perception and assessment of pain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02455609
Other Study ID Numbers  ICMJE 210
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmad Mohammad Abd El-Rahman, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmad M Abd El-Rahman, M.D. South Egypt Cancer Institute, Assiut University, Egypt
PRS Account Assiut University
Verification Date May 2015

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