Postoperative AnalgesiaNCT04374318
Comparison Between Intrathecal and Intravenous Dexmedetomidine
A study testing Dexmedetomidine in people with Postoperative Analgesia, run by Suez Canal University at 1 site in Egypt.
Trial summary
A prospective, randomized, comparative controlled clinical trial, aiming to compare the use of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 30 Mar 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients
- age 18-65 years
- scheduled for lower limb surgery
- spinal anaesthesia
Who cannot join
- patients with coagulopathy
- infection at the site of lumbar puncture
- beta-blockers or calcium channel blockers usage
- hypersensitivity to Bupivacaine or Dexmedetomidine
- any other contra-indications for spinal anaesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Study Between Intrathecal and Intravenous Dexmedetomidine in Lower Limb Surgeries
A prospective, randomized, comparative controlled clinical trial, aiming to compare the use of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.
Read the detailed description
Seventy patients undergoing lower limb surgeries were included in this study. Using a random number sequence, patients were enrolled in one of two groups: Group T receiving 5 µg of dexmedetomidine (Precedex® 100 µg/mL, Hospira, Inc., IL, U.S.A.) combined with 12.5 mg of 0.5% hyperbaric bupivacaine (Marcaine® Spinal Heavy; Astra, Sodertalje, Sweden) and Group V receiving the same bupivacaine DOSE AND 0.75 microgram/kilogram of body weight dexmedetomidine intravenously. Dexmedetomidine 100 µg/mL was mixed with preservative-free normal saline to 10 µg/mL. The 0.5 mL of dilute dexmedetomidine was added to the bupivacaine in group T. An independent investigator prepared the drug solutions and provided the coded drug to the anaesthetic administrator before the start of the anaesthesia. The anaesthetic administrator, patients, outcome assessors, and data analysts were blinded to the allocation. Spinal Anesthesia Patients were hydrated with 500 mL of 0.9% sodium chloride solution before anaesthesia. The spinal puncture was performed at L3-4 or L4-5 with a midline approach using a 25 G Quincke needle in the lateral decubitus position. After confirmation of free flow and clear cerebrospinal fluid, the drug was administered and the patients were then placed in the supine neutral position.
Assessment: The primary end-point of this study was the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.
- Conditions
- Postoperative Analgesia
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precidex
INTRATHECAL AND INTRAVENOUS
| Study group | Role | What they receive |
|---|---|---|
| IT intrathecal | Active comparator | administration of intrathecal dexmedetomidine in addition to bupivacaine for lower limb surgeries Receives: Drug: Dexmedetomidine |
| IV intravenous | Active comparator | administration of intravenous dexmedetomidine in addition to spinal anaesthesia for lower limb surgeries Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
First request to analgesia
The first time the patient is asking for analgesia to control his pain
Measured: Postoperative up to 24 hours
Secondary outcomes (2)
Total postoperative analgesia consumption
Total consumption of analgesia to control pain
Measured: Postoperative up to 24 hours
visual analogue scale
The score subjectively measures the severity of pain and it is ranging from 0 when there is no pain to 10 when it is the worse pain imaginable
Measured: Every two hours for 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Mar 2019
- Primary completion30 Oct 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
- Investigators
- Abdelrhman Alshawadfy, MD, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374318
- Sponsor's protocol ID
- Dex IT IV
- Status last verified
- May 2020
- First submitted
- 28 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study Between Intrathecal and Intravenous Dexmedetomidine in Lower Limb Surgeries
- ClinicalTrials.gov ID
- NCT04374318
- Acronym / sponsor ID
- Dex IT IV
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, randomized, comparative controlled clinical trial, aiming to compare the use of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.
Detailed description
Seventy patients undergoing lower limb surgeries were included in this study. Using a random number sequence, patients were enrolled in one of two groups: Group T receiving 5 µg of dexmedetomidine (Precedex® 100 µg/mL, Hospira, Inc., IL, U.S.A.) combined with 12.5 mg of 0.5% hyperbaric bupivacaine (Marcaine® Spinal Heavy; Astra, Sodertalje, Sweden) and Group V receiving the same bupivacaine DOSE AND 0.75 microgram/kilogram of body weight dexmedetomidine intravenously. Dexmedetomidine 100 µg/mL was mixed with preservative-free normal saline to 10 µg/mL. The 0.5 mL of dilute dexmedetomidine was added to the bupivacaine in group T. An independent investigator prepared the drug solutions and provided the coded drug to the anaesthetic administrator before the start of the anaesthesia. The anaesthetic administrator, patients, outcome assessors, and data analysts were blinded to the allocation. Spinal Anesthesia Patients were hydrated with 500 mL of 0.9% sodium chloride solution before anaesthesia. The spinal puncture was performed at L3-4 or L4-5 with a midline approach using a 25 G Quincke needle in the lateral decubitus position. After confirmation of free flow and clear cerebrospinal fluid, the drug was administered and the patients were then placed in the supine neutral position.
Assessment: The primary end-point of this study was the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IT intrathecal | Active comparator | Drug: Dexmedetomidineadministration of intrathecal dexmedetomidine in addition to bupivacaine for lower limb surgeries |
| IV intravenous | Active comparator | Drug: Dexmedetomidineadministration of intravenous dexmedetomidine in addition to spinal anaesthesia for lower limb surgeries |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-II patients
- age 18-65 years
- scheduled for lower limb surgery
- spinal anaesthesia
Key exclusion criteria (5 listed)
- patients with coagulopathy
- infection at the site of lumbar puncture
- beta-blockers or calcium channel blockers usage
- hypersensitivity to Bupivacaine or Dexmedetomidine
- any other contra-indications for spinal anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: precidexINTRATHECAL AND INTRAVENOUS | Drug | IT intrathecal, IV intravenous |
Primary outcome
First request to analgesia
Time frame: Postoperative up to 24 hours
The first time the patient is asking for analgesia to control his pain
2 secondary outcomes
Total postoperative analgesia consumption
Time frame: Postoperative up to 24 hours
visual analogue scale
Time frame: Every two hours for 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelrhman Alshawadfy, MD principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Postoperative Analgesia, run by Suez Canal 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 4 inclusion and 5 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 7 May 2020. 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. 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?
First request to analgesia (time frame: Postoperative up to 24 hours). 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 7 May 2020.