Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries
NCT ID: NCT03460041
Last Updated: 2018-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
36 participants
INTERVENTIONAL
2017-12-01
2018-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Thirty six patients will be randomly assigned using an online randomization program (http://www.randomizer.org) and the sealed envelope method into three groups: Group D (n=12): Dexmetedomidine group. 0.5 ml of dexmetedomidine (2 μg/kg) added to bupivacaine, Group M (n=12) : Magnesium group.0.5 ml of magnesium sulphate (50 mg) added to bupivacaine, Group C (n=12) :Control group.bupivacaine 0.25% diluted in normal saline with total volume of 1 ml/kg.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries
NCT02487355
Intraperitoneal Magnesium Sulphate and Bupivacaine Versus Intravenous Analgesia in Laparoscopic Surgeries in Pediatrics
NCT04651556
Dexmedetomidine Added to Bupivacaine for ESP Block in Children Undergoing Lower Abdominal Surgeries
NCT07023991
Intraperitoneal Analgesia in Pediatric Laparoscopy
NCT02820610
Dexmedetomidine Versus Magnesium Sulphate Added to Bupivacaine in Infraorbital Nerve Block for Perioperative Analgesia in Paediatric Patients for Cleft Lip Surgery
NCT05624151
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Inhalational induction of anesthesia will be achieved by 8% sevoflurane in 100% oxygen and an appropriate-sized cannula will be inserted. Endotracheal intubation will be performed after which sevoflurane concentration will be reduced to 3%. After hemodynamic stabilization, caudal block will be performed by using beveled needle 18-23 G in the lateral decubitus position by using the loss of resistance technique. The study solutions will be injected caudally slowly with repetitive intermittent aspiration by an anesthesiologist blinded to the test drugs. The inhaled concentration of sevoflurane will be adjusted to achieve hemodynamic changes less than 30% of the preoperative values
Recorded Parameters for the study:
Intraoperative hemodynamic: heart rates (beats/minutes), mean arterial blood pressure (mmHg) after stabilization, before skin incision and every 15 minutes till the end of surgery.
Sedation score: Sedation will be monitored after PACU arrival using Ramsay score with its 0-6 score range.
Pain score (FLACC score) with its 0-10 score range, each patient pain intensity will be assessed at the end of surgery and 12 hours postoperatively.
Time of rescue analgesia (from the time of caudal injection to the time at which FLACC score 4 or more) will be recorded.
Complication secondary to test drugs in the form of toxicity like postoperative nausea and vomiting, respiratory depression, hematoma, bradycardia (HR \<80 BPM) and hypotension (SBP \<70 mmhg+ age in years \* 2) and complication secondary to caudal block; infection, hematoma and pain at the site of injection will be recorded.
Total doses of rescue drugs will be calculated for each group.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Bupivacaine
Caudal bupivacaine for pain management
Magnesium
Magnesium Sulfate
caudal magnesium sulphate added to bupivacaine for pain management
Dexmetedomedine
Dexmetedomedine
Caudal dexmetedomedine added to bupivacaine for pain management
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnesium Sulfate
caudal magnesium sulphate added to bupivacaine for pain management
Dexmetedomedine
Caudal dexmetedomedine added to bupivacaine for pain management
Bupivacaine
Caudal bupivacaine for pain management
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* American Society of Anesthesiologist (ASA) physical status class I- II.
* Patients scheduled for infra-umbilical orthopedic surgeries.
Exclusion Criteria
* Suspected coagulopathy.
* Infection at the site of caudal block.
* History of developmental delay or neuromuscular disorders.
* Skeletal deformities.
* Patients on magnesium therapy
1 Year
7 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Hagar hassanein refaee
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hagar hassanein refaee
Assistant lecturer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cairo University faculty
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Mai Ahmed Aly, Lecturer
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Cairo University
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N-59-2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.