Hypotension During SurgeryPhase 4NCT07052864
IV Dexamethasone in Preventing Post Spinal Hypotension
A Phase 4 study testing Dexamethasone in people with Hypotension During Surgery, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Orthopedic lower limb procedures are carried out under spinal anesthesia which involves administration of drugs in the space surrounding the spinal cord. From there the drug acts on the spinal cord blocking electrical signals moving across nerve fibers thereby providing sufficient pain relief and surgical conditions. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2025to 5 Aug 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing orthopedic surgery under spinal anaesthesia.
- ASA I \& II.
Who cannot join
- Known case of ischemic heart disease.
- Patients having contraindication to spinal anesthesia (e.g.- coagulopathy, thrombocytopenia, allergy to local anesthetic agent).
- Patients using corticosteroids or drugs that affect serotonin (e.g., selective serotonin reuptake inhibitor).
- Patients with uncorrected hypovolemia.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences
Islamabad, Federal, 44000
About this study
Official title: Efficacy of Dexamethasone in Preventing Postspinal Hypotension in Elderly Patients Undergoing Orthopedic Surgery: a Randomized Controlled Study
Orthopedic lower limb procedures are carried out under spinal anesthesia which involves administration of drugs in the space surrounding the spinal cord. From there the drug acts on the spinal cord blocking electrical signals moving across nerve fibers thereby providing sufficient pain relief and surgical conditions. However blocking of these fibers result in reduce signal transmission to blood vessels and heart resulting in fall in blood pressure. Various drugs can be used to treat or prevent this hypotension. One such drug is Dexamethasone which is a steroid. This drug can be administered before spinal anesthesia through Intravenous route to prevent fall in blood pressure.
Read the detailed description
Lower limb orthopedic surgeries are carried out under Sub Arachnoid block which is associated with sympathectomy resulting in vasodilation and hypotension. The hypotension can compromise end organ perfusion and pre-disposes the person to end organ damage such as Myocardial infarction, stroke and renal injury. Therefore treatment and prevention of post spinal hypotension is one of the major goals to improve peri-operative outcomes. One such drug which can be used to prevent post spinal hypotension is Dexamethasone which can be given prophylactically to prevent post spinal hypotension as the drug causes increase in systemic vascular resistance thereby counteracting post spinal vasodilation and hypotension.
- Conditions
- Hypotension During Surgery
- Being tested
- Dexamethasone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
8 mg of Intravenous Dexamethasone in 100 ml Normal saline given 1 hour before anesthesia induction
PlaceboDrug
Also called Normal Saline
100ml of Normal saline administration 1 hour before anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Group Dexamethasone | Experimental | Participants entering this arm of Parallel randomized control trial will receive 8mg of IV Dexamethasone in 100ml Normal saline 1 hour before induction of spinal anesthesia. Receives: Drug: Dexamethasone |
| Group Placebo | Placebo comparator | Participants entering this arm of Parallel randomized control trial will receive 100ml Normal saline 1 hour before induction of spinal anesthesia. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
This is the highest blood pressure during cardiac cycle occurring at the peak of systole measured by Non invasive automated blood pressure cuff
Measured: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins
Diastolic Blood Pressure
This is the lowest blood pressure during cardiac cycle measured by Non invasive automated blood pressure cuff
Measured: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins
Mean Blood Pressure
This is the average blood pressure during cardiac cycle measured by Non invasive automated blood pressure cuff
Measured: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins
Secondary outcomes (3)
Number of Hypotensive episodes
This will be the number of times in the intraoperative period the patient experience fall in either systolic, diastolic or mean blood pressure by more than 20% from baseline
Measured: Intraoperative period
Rescue Phenylephrine
This will be the total amount of phenylephrine administered in intraoperative period to the patient in case of fall in either systolic, diastolic or mean blood pressure by more than 20% from baseline
Measured: Intraoperative period
Rescue intravenous fluid
This will be the total amount of IV crystalloid fluid administered in intraoperative period to the patient in case of fall in either systolic, diastolic or mean blood pressure by more than 20% from baseline
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2025
- Study start30 Jun 2025
- Primary completion5 Aug 2025 (estimated)
- Study completion5 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypotension During SurgeryStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After taking informed consent participants will be divided into two equal groups using computer generated random numbers. The participants in group D will receive 8 mg of IV Dexamethasone in 100ml Normal saline 1 hour before induction of spinal anesthesia while participants in group C will receive 100ml of Normal saline 1 hour before induction of spinal anesthesia. 1 hour after administration of IV Dexamethasone or placebo patient will be brought into OR, ASA monitoring will be attached, Sub Arachnoid block will be induced with 15mg of hyperbaric bupivacaine, patient will be made to lie down, level of block will be assessed and surgery will be started. Intraoperatively hemodynamics will be recorded at 5 minutes interval for first 30 minutes. Any fall in blood pressure by more than 20% from baseline will be noted and treated with Phenylephrine IV bolus.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Haroon Anwar, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052864
- Sponsor's protocol ID
- F.5-2/2024(ERRC)/PIMS
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashoor TM, Hussien NS, Anis SG, Esmat IM. Dexamethasone blunts postspinal hypotension in geriatric patients undergoing orthopedic surgery: a double blind, placebo-controlled study. BMC Anesthesiol. 2021 Jan 11;21(1):11. doi: 10.1186/s12871-021-01232-w.
PubMed 33430772
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexamethasone in Preventing Postspinal Hypotension in Elderly Patients Undergoing Orthopedic Surgery: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07052864
- Acronym / sponsor ID
- F.5-2/2024(ERRC)/PIMS
- Conditions
- Hypotension During Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 5 Aug 2025 (estimated)
- Study completion
- 5 Aug 2025 (estimated)
- First posted
- 7 Jul 2025 (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.
Orthopedic lower limb procedures are carried out under spinal anesthesia which involves administration of drugs in the space surrounding the spinal cord. From there the drug acts on the spinal cord blocking electrical signals moving across nerve fibers thereby providing sufficient pain relief and surgical conditions. However blocking of these fibers result in reduce signal transmission to blood vessels and heart resulting in fall in blood pressure. Various drugs can be used to treat or prevent this hypotension. One such drug is Dexamethasone which is a steroid. This drug can be administered before spinal anesthesia through Intravenous route to prevent fall in blood pressure.
Detailed description
Lower limb orthopedic surgeries are carried out under Sub Arachnoid block which is associated with sympathectomy resulting in vasodilation and hypotension. The hypotension can compromise end organ perfusion and pre-disposes the person to end organ damage such as Myocardial infarction, stroke and renal injury. Therefore treatment and prevention of post spinal hypotension is one of the major goals to improve peri-operative outcomes. One such drug which can be used to prevent post spinal hypotension is Dexamethasone which can be given prophylactically to prevent post spinal hypotension as the drug causes increase in systemic vascular resistance thereby counteracting post spinal vasodilation and hypotension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- After taking informed consent participants will be divided into two equal groups using computer generated random numbers. The participants in group D will receive 8 mg of IV Dexamethasone in 100ml Normal saline 1 hour before induction of spinal anesthesia while participants in group C will receive 100ml of Normal saline 1 hour before induction of spinal anesthesia. 1 hour after administration of IV Dexamethasone or placebo patient will be brought into OR, ASA monitoring will be attached, Sub Arachnoid block will be induced with 15mg of hyperbaric bupivacaine, patient will be made to lie down, level of block will be assessed and surgery will be started. Intraoperatively hemodynamics will be recorded at 5 minutes interval for first 30 minutes. Any fall in blood pressure by more than 20% from baseline will be noted and treated with Phenylephrine IV bolus.
| Arm | Type | Receives |
|---|---|---|
| Group Dexamethasone | Experimental | Drug: DexamethasoneParticipants entering this arm of Parallel randomized control trial will receive 8mg of IV Dexamethasone in 100ml Normal saline 1 hour before induction of spinal anesthesia. |
| Group Placebo | Placebo comparator | Drug: PlaceboParticipants entering this arm of Parallel randomized control trial will receive 100ml Normal saline 1 hour before induction of spinal anesthesia. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing orthopedic surgery under spinal anaesthesia.
- ASA I \& II.
Key exclusion criteria (4 listed)
- Known case of ischemic heart disease.
- Patients having contraindication to spinal anesthesia (e.g.- coagulopathy, thrombocytopenia, allergy to local anesthetic agent).
- Patients using corticosteroids or drugs that affect serotonin (e.g., selective serotonin reuptake inhibitor).
- Patients with uncorrected hypovolemia.
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 |
|---|---|---|
| Dexamethasone8 mg of Intravenous Dexamethasone in 100 ml Normal saline given 1 hour before anesthesia induction | Drug | Group Dexamethasone |
| PlaceboAlso: Normal Saline100ml of Normal saline administration 1 hour before anesthesia induction | Drug | Group Placebo |
Primary outcome
Systolic Blood Pressure
Time frame: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins
This is the highest blood pressure during cardiac cycle occurring at the peak of systole measured by Non invasive automated blood pressure cuff
Diastolic Blood Pressure
Time frame: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins
This is the lowest blood pressure during cardiac cycle measured by Non invasive automated blood pressure cuff
Mean Blood Pressure
Time frame: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins
This is the average blood pressure during cardiac cycle measured by Non invasive automated blood pressure cuff
3 secondary outcomes
Number of Hypotensive episodes
Time frame: Intraoperative period
Rescue Phenylephrine
Time frame: Intraoperative period
Rescue intravenous fluid
Time frame: Intraoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 33430772Ashoor TM, Hussien NS, Anis SG, Esmat IM. Dexamethasone blunts postspinal hypotension in geriatric patients undergoing orthopedic surgery: a double blind, placebo-controlled study. BMC Anesthesiol. 2021 Jan 11;21(1):11. doi: 10.1186/s12871-021-01232-w.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hypotension During Surgery
Not yet recruitingPhase 4
OB VEGA-Phenylephrine vs Norepinephrine Outcomes
Hypotension During Surgery, Cesarean Birth
Not yet recruitingPhase 4
Effects of Ondansetron Timing During Spinal Anesthesia for Urologic Surgery
Spinal Anesthesia-Induced Hypotension, Cerebral Oxygenation
Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries
Not yet recruitingObservational study
Carotid Artery Blood Flow, Blood Pressure, and Cardiac Output During Anesthesia in Children Aged 0-5 Years
Hypotension (MeSH: D007022)
RecruitingPhase 4
Modified Saddle Block vs Spinal Anesthesia for TURP
TURP(Transurethral Resection of Prostate), Spinal Anesthesia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Hypotension During Surgery, run by Pakistan Institute of Medical Sciences 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Systolic Blood Pressure (time frame: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07052864, which also lists 1 linked publication.
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 Jul 2025.