DexmedetomidineNCT05525819
Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection
A study testing Intrathecal group and Intravenous group in people with Dexmedetomidine and Transurethral Resection of Prostate, run by Tanta University at 1 site in Egypt.
Trial summary
This study was conducted to compare the effects of intrathecal versus intravenous dexmedetomidine administration in patients undergoing Transurethral resection of the prostate under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Dexmedetomidine, Transurethral Resection of Prostate, Analgesia
- What is being tested?
- Intrathecal group and Intravenous group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 29 Apr 2023
- 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 50 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases aged between 50 and 70 years
- Having class I or II according to the American society of anesthesiologists (ASA)
Who cannot join
- Cases with heart block
- Dysrhythmia
- Contraindications for spinal anesthesia
- Known allergy to the study medications
- Classified as ASA class > II
- Alpha 2 agonist or antagonist therapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt
Tanta, ElGharbia, 31511
Laila Elahwal, MD, 1018484319 ext. +20, Lailaelahwal@gmail.com
About this study
Official title: The Effect of Intrathecal Versus Intravenous Dexmedetomidine on Postoperative Analgesia in Transurethral Resection of The Prostate
This study was conducted to compare the effects of intrathecal versus intravenous dexmedetomidine administration in patients undergoing Transurethral resection of the prostate under spinal anesthesia.
Read the detailed description
Multiple prostatic pathologies become evident in the elderly males. Of them, benign prostatic hyperplasia is one of the most prevalent issues in aging men and transurethral resection of the prostate (TURP) still represents the standard surgical treatment.
Most transurethral resection of the prostate (TURP) procedures are performed under spinal anesthesia. Spinal anesthesia has many advantages including, easy application, low cost, decreasing the risk of aspiration, decreasing intraoperative bleeding, eliminating the need for mechanical ventilation together with the decreased risk of intraoperative cardiac events or post-operative hypoxic episode.
The management of post-operative pain following spinal anesthesia using a short-acting anesthetic still constitutes a major problem for anesthesiologists and pain physicians. However, the duration and efficacy of spinal anesthesia could be improved by adjuvants.
Dexmedetomidine is an alpha 2 receptor agonist that have antinociceptive action for both visceral and somatic pain. At low doses, it has sedative and hypnotic effects without having a negative impact on respiration. Multiple studies have reported that intrathecal and intravenous administration of this drug could prolong the duration of spinal anesthesia and post-operative analgesia.
- Being tested
- Control group, Intrathecal group, Intravenous group
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDrug
The cases will be subjected to spinal anesthesia with a 3 ml volume (2.5 ml of hyperbaric bupivacaine 10 mg in addition to 0.5 normal saline). 50 ml of normal saline was infused over a ten-minute period, followed by 200 ml infusion till the end of operation.
Intrathecal groupDrug
The cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg in the saline component. 50 ml of normal saline was infused over a ten-minute period, followed by 200 ml infusion till the end of operation.
Intravenous groupDrug
The intravenous group will receive 2.5 ml of hyperbaric bupivacaine (10 mg), in addition to intravenous dexmedetomidine, which will be started at 1 μg/kg loading dose diluted in 50 ml saline administered within 10 min, followed by maintenance at a 0.4 μg/kg/h dose diluted in 200 ml saline till the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Cases will be subjected to spinal anesthesia with hyperbaric bupivacaine 10 mg. Receives: Drug: Control group |
| Intrathecal group | Experimental | Cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg. Receives: Drug: Intrathecal group |
| Intravenous group | Experimental | Cases will receive hyperbaric bupivacaine (10 mg), in addition to IV dexmedetomidine (1 μg/kg loading dose, followed by 0.4 μg/kg/h maintenance dose). Receives: Drug: Intravenous group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic request
Time to first analgesic request will be recorded
Measured: 24 hours postoperatively
Secondary outcomes (5)
The onset of sensory
Time to reach T7 sensory block will be recorded
Measured: 24 hours Postoperatively
The degree of motor block
The degree of motor block will be assessed using the modified Bromage Score. Grade 0 No motor block Grade 1 Inability to raise extended leg, able to move knees and feet Grade 2 Inability to raise extended leg and move knee, able to move feet Grade 3 Complete motor block of the lower limbs.
Measured: 24 hours Postoperatively
Sedation level
Patients level of sedation will be assessed via Ramsay sedation score. This score is numbered from 1 to 6, based on patient responsiveness.
Measured: Intraoperativley
Total analgesic requirements
Total analgesic requirements will be recorded
Measured: 48 hours Postoperatively
The incidence of side effects
The incidence of side effects including (bradycardia, hypotension, nausea, vomiting, and pruritis) will be recorded..
Measured: 48 hours Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Sep 2022
- Primary completion29 Apr 2023 (estimated)
- Study completion29 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laila Elahwal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525819
- Sponsor's protocol ID
- 34141/9/20
- Status last verified
- Sep 2022
- First submitted
- 29 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information will be available under a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intrathecal Versus Intravenous Dexmedetomidine on Postoperative Analgesia in Transurethral Resection of The Prostate
- ClinicalTrials.gov ID
- NCT05525819
- Acronym / sponsor ID
- 34141/9/20
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 29 Apr 2023 (estimated)
- Study completion
- 29 Apr 2023 (estimated)
- First posted
- 2 Sep 2022 (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.
This study was conducted to compare the effects of intrathecal versus intravenous dexmedetomidine administration in patients undergoing Transurethral resection of the prostate under spinal anesthesia.
Detailed description
Multiple prostatic pathologies become evident in the elderly males. Of them, benign prostatic hyperplasia is one of the most prevalent issues in aging men and transurethral resection of the prostate (TURP) still represents the standard surgical treatment.
Most transurethral resection of the prostate (TURP) procedures are performed under spinal anesthesia. Spinal anesthesia has many advantages including, easy application, low cost, decreasing the risk of aspiration, decreasing intraoperative bleeding, eliminating the need for mechanical ventilation together with the decreased risk of intraoperative cardiac events or post-operative hypoxic episode.
The management of post-operative pain following spinal anesthesia using a short-acting anesthetic still constitutes a major problem for anesthesiologists and pain physicians. However, the duration and efficacy of spinal anesthesia could be improved by adjuvants.
Dexmedetomidine is an alpha 2 receptor agonist that have antinociceptive action for both visceral and somatic pain. At low doses, it has sedative and hypnotic effects without having a negative impact on respiration. Multiple studies have reported that intrathecal and intravenous administration of this drug could prolong the duration of spinal anesthesia and post-operative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Drug: Control groupCases will be subjected to spinal anesthesia with hyperbaric bupivacaine 10 mg. |
| Intrathecal group | Experimental | Drug: Intrathecal groupCases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg. |
| Intravenous group | Experimental | Drug: Intravenous groupCases will receive hyperbaric bupivacaine (10 mg), in addition to IV dexmedetomidine (1 μg/kg loading dose, followed by 0.4 μg/kg/h maintenance dose). |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cases aged between 50 and 70 years
- Having class I or II according to the American society of anesthesiologists (ASA)
Key exclusion criteria (6 listed)
- Cases with heart block
- Dysrhythmia
- Contraindications for spinal anesthesia
- Known allergy to the study medications
- Classified as ASA class > II
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 |
|---|---|---|
| Control groupThe cases will be subjected to spinal anesthesia with a 3 ml volume (2.5 ml of hyperbaric bupivacaine 10 mg in addition to 0.5 normal saline). 50 ml of normal saline was infused over a ten-minute period, followed by 200 ml infusion till the end of operation. | Drug | Control group |
| Intrathecal groupThe cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg in the saline component. 50 ml of normal saline was infused over a ten-minute period, followed by 200 ml infusion till the end of operation. | Drug | Intrathecal group |
| Intravenous groupThe intravenous group will receive 2.5 ml of hyperbaric bupivacaine (10 mg), in addition to intravenous dexmedetomidine, which will be started at 1 μg/kg loading dose diluted in 50 ml saline administered within 10 min, followed by maintenance at a 0.4 μg/kg/h dose diluted in 200 ml saline till the end of the procedure. | Drug | Intravenous group |
Primary outcome
Time to first analgesic request
Time frame: 24 hours postoperatively
Time to first analgesic request will be recorded
5 secondary outcomes
The onset of sensory
Time frame: 24 hours Postoperatively
The degree of motor block
Time frame: 24 hours Postoperatively
Sedation level
Time frame: Intraoperativley
Total analgesic requirements
Time frame: 48 hours Postoperatively
The incidence of side effects
Time frame: 48 hours Postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: Yes. All information will be available under a reasonable request from the corresponding author
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal group and Intravenous group in people with Dexmedetomidine and Transurethral Resection of Prostate, 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laila Elahwal, MD (1018484319 ext. +20, Lailaelahwal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first analgesic request (time frame: 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 6 Sep 2022.