Haemodynamic InstabilityPhase 3NCT05285800
To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP
A Phase 3 study testing 0.5% Hyperbaric Bupivacaine in people with Haemodynamic Instability, run by Hamdard University at 1 site in Pakistan.
Trial summary
To determine the effectiveness of saddle block vs spinal anesthesia in TURP. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Haemodynamic Instability
- What is being tested?
- 0.5% Hyperbaric Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Sep 2021to 6 Mar 2022
- Phase
- Phase 3
- 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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with absolute contraindication of general anaesthsia
- Patients who gave consent and willing to be included in study
- Patient's having age range between 45 years to 65years
- Well controlled diabetes and hypertension
- ASA grade I \& II
Who cannot join
- Patients with absolute contraindications of regional anesthesia,
- Deformity of vertebral column,
- Thyroid disorder,
- Psychiatric illness,
- Neurological diseases,
- Alcohol addiction,
Show all 9Show fewer
- Smoking,
- Ischemic heart diseases and
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effectiveness of saddle block vs spinal anesthesia in TURP.
Read the detailed description
This study is being conducted to determine the effectiveness of saddle block vs spinal anesthesia in terms of haemodynamic stability and Vasopressor usage.
- Conditions
- Haemodynamic Instability
- Being tested
- 0.5% Hyperbaric Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% Hyperbaric BupivacaineDrug
Also called Hyperbaric Bupivacaine
In both groups 0.5% Hyperbaric Bupivacaine is given intrathecally and then saddle group is advised to stay in sitting position for next 5minutes so that drug can block only lower segments of nerves, Lumber 5th to Sacral dermatomes level. The spinal group is advised to take supine position immediately so that drug distribution be uniform uptill T10 level of spinal dermatome. Then outcomes regarding haemodynamic status and vasopressor usage are recorded
| Study group | Role | What they receive |
|---|---|---|
| Saddle group | Experimental | After administration of 12mg of 0.5 % Hyperbaric Bupivacaine intrathecally, Patient is advised to remain in Sitting position for the next 5minutes and then take supine position Receives: Drug: 0.5% Hyperbaric Bupivacaine |
| Spinal group | Active comparator | After administration of 12mg of 0.5% Hyperbaric Bupivacaine intrathecally, Patient is advised to take Supine position immediately. Receives: Drug: 0.5% Hyperbaric Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamic status
Haemodynamic status includes pulse rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation.
Pulse rate ranges between 60-100 beats/ minute. Pulse above 100 is called tachycardia and below 60 is called bradycardia Systolic blood pressure more than 140mmhg is called systolic hypertension and lower than 90mmhg is known as systolic hypotension.
Diastolic blood pressure more than 90mmhg is called diastolic hypertension and lower than 60mmhg is called diastolic hypotension.
Mean arterial pressure ranges between 70-110. More than 110 labeled as hypertension and below 70 means hypotension.
Spo2 level below 94% is labeled as hypoxia.
Measured: Haemodynamic status checked from 0minutes ( as the patient takes supine position) for every 5minutes interval till the end of surgery.
Vasopressor usage
The main side effect of intrathecal 0.5 % hyperbaric Bupivacaine is hypotension. That is countered by using vasopressor drug e.g inj. Ephedrine. Critically low blood pressure e.g systolic bp below 90mmhg, diastole c blood pressure below 60mmh and MAP below 60 is an indication for vasopressor introduction.
Measured: Blood pressure is taken from 0minute (as the patient takes supine position) at every ⁵minutes interval till the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start6 Sep 2021
- Primary completion6 Mar 2022
- Study completion6 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodynamic InstabilityStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In Both the groups after injecting 0.5% hyperbaric Bupivacaine intrathecally the outcomes are monitored and compared.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Muhammad Wajid Iqbal, Hamdard University
- Investigators
- Dr. Wajid Iqbal, MBBS, MCPS, Principal investigator, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285800
- Sponsor's protocol ID
- W0333
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the study protocol and outcome data will be shared with other researchers in private if the need
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP
- ClinicalTrials.gov ID
- NCT05285800
- Acronym / sponsor ID
- W0333
- Conditions
- Haemodynamic Instability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 6 Mar 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 18 Mar 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.
To determine the effectiveness of saddle block vs spinal anesthesia in TURP.
Detailed description
This study is being conducted to determine the effectiveness of saddle block vs spinal anesthesia in terms of haemodynamic stability and Vasopressor usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In Both the groups after injecting 0.5% hyperbaric Bupivacaine intrathecally the outcomes are monitored and compared.
| Arm | Type | Receives |
|---|---|---|
| Saddle group | Experimental | Drug: 0.5% Hyperbaric BupivacaineAfter administration of 12mg of 0.5 % Hyperbaric Bupivacaine intrathecally, Patient is advised to remain in Sitting position for the next 5minutes and then take supine position |
| Spinal group | Active comparator | Drug: 0.5% Hyperbaric BupivacaineAfter administration of 12mg of 0.5% Hyperbaric Bupivacaine intrathecally, Patient is advised to take Supine position immediately. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with absolute contraindication of general anaesthsia
- Patients who gave consent and willing to be included in study
- Patient's having age range between 45 years to 65years
- Well controlled diabetes and hypertension
- ASA grade I \& II
Key exclusion criteria (9 listed)
- Patients with absolute contraindications of regional anesthesia,
- Deformity of vertebral column,
- Thyroid disorder,
- Psychiatric illness,
- Neurological diseases,
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 |
|---|---|---|
| 0.5% Hyperbaric BupivacaineAlso: Hyperbaric BupivacaineIn both groups 0.5% Hyperbaric Bupivacaine is given intrathecally and then saddle group is advised to stay in sitting position for next 5minutes so that drug can block only lower segments of nerves, Lumber 5th to Sacral dermatomes level. The spinal group is advised to take supine position immediately so that drug distribution be uniform uptill T10 level of spinal dermatome. Then outcomes regarding haemodynamic status and vasopressor usage are recorded | Drug | Saddle group, Spinal group |
Primary outcome
Haemodynamic status
Time frame: Haemodynamic status checked from 0minutes ( as the patient takes supine position) for every 5minutes interval till the end of surgery.
Haemodynamic status includes pulse rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation. Pulse rate ranges between 60-100 beats/ minute. Pulse above 100 is called tachycardia and below 60 is called bradycardia Systolic blood pressure more than 140mmhg is called systolic hypertension and lower than 90mmhg is known as systolic hypotension. Diastolic blood pressure more than 90mmhg is called diastolic hypertension and lower than 60mmhg is called diastolic hypotension. Mean arterial pressure ranges between 70-110. More than 110 labeled as hypertension and below 70 means hypotension. Spo2 level below 94% is labeled as hypoxia.
Vasopressor usage
Time frame: Blood pressure is taken from 0minute (as the patient takes supine position) at every ⁵minutes interval till the end of surgery
The main side effect of intrathecal 0.5 % hyperbaric Bupivacaine is hypotension. That is countered by using vasopressor drug e.g inj. Ephedrine. Critically low blood pressure e.g systolic bp below 90mmhg, diastole c blood pressure below 60mmh and MAP below 60 is an indication for vasopressor introduction.
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 31 Mar 2022.
- Individual participant dataSharing planned: No. Only the study protocol and outcome data will be shared with other researchers in private if the need
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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.
Dr. Wajid Iqbal, MBBS, MCPS principal investigator
Hamdard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.5% Hyperbaric Bupivacaine in people with Haemodynamic Instability, run by Hamdard University at 1 site in Pakistan.
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 5 inclusion and 9 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 31 Mar 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 Pakistan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Haemodynamic status (time frame: Haemodynamic status checked from 0minutes ( as the patient takes supine position) for every 5minutes interval till the end of surgery.). The study lists 2 primary outcomes in all. 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 31 Mar 2022.