DexamethasonePhase 4NCT07819682
Dexamethasone and Duration of Spinal Anesthesia
A Phase 4 study testing Dexamethasone in people with Dexamethasone and Spinal Anesthesia, run by Holy Family Hospital, Pakistan at 1 site in Pakistan.
Trial summary
This study will evaluate whether intravenous dexamethasone affects the duration of spinal anesthesia in patients undergoing lower abdominal surgery. Eligible adult patients classified as ASA I or II will undergo routine preoperative assessment by an anesthetist. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dexamethasone, Spinal Anesthesia, Adjuvant
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2026to 15 Dec 2026
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing lower abdominal surgeries and orthopaedic surgeries including pelvic and lower extremity surgeries
- Patients classified as American Society of Anesthesiologists (ASA) physical status I or II
Who cannot join
- Patients with a history of spinal surgery, spinal instrumentation, or previous failed spinal anaesthesia
- Patients with pre-existing neurological disorders, peripheral neuropathy, or sensory/motor deficits
- Patients with known hypersensitivity or allergy to local anaesthetic agents or dexamethasone
- Patients with congenital spinal deformities or acquired spinal conditions such as advanced spondylosis or kyphoscoliosis that may interfere with neuraxial block
- Patients with contraindications to spinal anaesthesia, including coagulopathy, local infection at the injection site, or raised intracranial pressure
- Patients with diabetes mellitus, chronic steroid therapy, immunosuppression, or systemic infection (due to steroid use)
- Pregnant patients or those undergoing emergency surgeries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Holy Family Hospital
Rawalpindi, Punjab Province, 46000
Jawad Zaheer, MBBS, FCPS, +92 333 5428866, drjayzee@hotmail.com
About this study
Official title: Effect of Intravenous Dexamethasone on The Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery-Quasi Experimental Study
This study will evaluate whether intravenous dexamethasone affects the duration of spinal anesthesia in patients undergoing lower abdominal surgery.
Eligible adult patients classified as ASA I or II will undergo routine preoperative assessment by an anesthetist. Before surgery, patients will receive either intravenous dexamethasone (8 mg diluted in 100 mL normal saline) or 100 mL normal saline alone. The medication will be administered through a peripheral intravenous cannula.
Read more
Spinal anesthesia will then be performed using a standard technique. A 25-gauge spinal needle will be used to administer 12-15 mg of 0.75% hyperbaric bupivacaine into the lower lumbar region while the patient is in the sitting position. After confirming the flow of cerebrospinal fluid, the patient will be positioned for surgery.
The level and effectiveness of anesthesia will be assessed using standard sensory and motor assessments. Surgery will begin after an adequate level of numbness and motor block has been achieved. The recovery of sensory and motor function will subsequently be assessed at regular 15-minute intervals by an anesthesia team member who was not involved in administering the spinal anesthesia, to minimize assessment bias.
The main outcome will be the time required for the sensory block to regress from its initial level to the lower thoracic region (T10-T12). Additional outcomes will include the total duration of sensory and motor block and postoperative pain, assessed using a visual pain scale four hours after surgery.
Patient information such as age, sex, diagnosis, type of surgery, duration of sensory and motor block, and postoperative pain score will be recorded and analyzed to determine whether intravenous dexamethasone prolongs the duration of spinal anesthesia.
Read the detailed description
This study will evaluate the effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in patients undergoing lower abdominal surgery.
Eligible patients will be adults classified as American Society of Anesthesiologists (ASA) physical status I or II and meeting the predefined inclusion and exclusion criteria. All patients will undergo a preoperative assessment by a consultant anesthetist and will be deemed fit for anesthesia and surgery before enrollment.
After establishment of standard monitoring in the operating theatre, an 18-gauge peripheral intravenous cannula will be secured. Patients will receive either 8 mg of dexamethasone diluted in 100 mL of normal saline or 100 mL of normal saline alone, according to the study protocol. The administration will be performed in a manner intended to maintain blinding of the personnel responsible for subsequent assessment of block regression.
Following the intravenous intervention, spinal anesthesia will be performed using a 25-gauge spinal needle with the patient in the sitting position. A dose of 12-15 mg of 0.75% hyperbaric bupivacaine will be administered intrathecally at the L3-L4 or L4-L5 intervertebral space. Correct intrathecal placement will be confirmed by free flow of cerebrospinal fluid through the spinal needle. The patient will subsequently be positioned supine.
The sensory block will be assessed by testing the response to pinprick at the relevant dermatomes, while the degree of motor blockade will be assessed using the Modified Bromage Scale. Surgery will commence after an adequate sensory block extending to the T4 dermatome and a Modified Bromage score of 1 have been achieved.
Following establishment of spinal anesthesia, serial assessments of sensory and motor blockade will be performed at 15-minute intervals by a member of the anesthesia team who was not involved in administration of the spinal anesthetic, in order to minimize assessment bias. Sensory block regression will be assessed sequentially at the dermatomes from T4 toward the lower thoracic levels. The primary outcome will be the duration from establishment of the sensory block until regression to the T10-T12 dermatome level.
Following surgery, patients will be transferred to the Post-Anesthesia Care Unit (PACU), where continued assessment of the sensory and motor blockade will be performed. The total duration of sensory blockade and motor blockade will be recorded. Postoperative pain intensity will be assessed using the Visual Analogue Scale (VAS) at 4 hours after surgery.
The study will collect demographic and clinical variables, including age, sex, primary diagnosis, and type of surgical procedure. Quantitative outcome measures will include the time required for sensory block regression to the T10-T12 level, total duration of sensory blockade, total duration of motor blockade, and postoperative pain intensity at 4 hours. These outcomes will be compared to determine whether intravenous dexamethasone prolongs the duration of hyperbaric bupivacaine spinal anesthesia and influences postoperative analgesic outcomes.
- Conditions
- Dexamethasone, Spinal Anesthesia, Adjuvant
- Being tested
- Dexamethasone, Placebo
- Keywords
- Dexamethasone, Lower Abdominal Surgery, Spinal Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Will receive 8mg of Dexamethasone in 100ml of Normal saline 10 minutes prior to induction of Anesthesia
PlaceboDrug
Will receive 100ml Normal saline 10 minutes prior to induction of spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group Dexamethasone | Active comparator | 8mg of Dexamethasone in 100ml Normal Saline will be administered Receives: Drug: Dexamethasone |
| Control group | Placebo comparator | Will receive 100ml of normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Spinal Anesthesia regression
Time in minutes from administration of spinal anesthesia until sensory block regresses by two dermatomes from the maximum sensory block level.
Measured: From administration of spinal anesthesia until sensory block regresses by two dermatomes, assessed for up to 6 hours after spinal anesthesia
Time in minutes from administration of spinal anesthesia until the patient first requests rescue analgesia.
Measured: From administration of spinal anesthesia until the patient's first request for rescue analgesia, assessed for up to 6 hours after spinal anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start15 Aug 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (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 DexamethasoneStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holy Family Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tayyab Masood, Holy Family Hospital, Pakistan
- Investigators
- Jawad Zaheer, MBBS, FCPS, Study chair, Head of Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819682
- Sponsor's protocol ID
- 782/REF/RMU/2025
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed by Ethical committee
Publications
Abdel-Wahab AH, Abd Alla ES, Abd El-Azeem T. Effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in lower abdominal surgery, Randomized controlled trial. BMC Anesthesiol. 2023 Sep 22;23(1):323. doi: 10.1186/s12871-023-02282-y.
PubMed 37736711
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Dexamethasone on The Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery-Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT07819682
- Acronym / sponsor ID
- 782/REF/RMU/2025
- Conditions
- Dexamethasone, Spinal Anesthesia, Adjuvant
- Keywords
- Dexamethasone, Lower Abdominal Surgery, Spinal Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Holy Family Hospital, PakistanUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 15 Sep 2026 (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 will evaluate whether intravenous dexamethasone affects the duration of spinal anesthesia in patients undergoing lower abdominal surgery.
Eligible adult patients classified as ASA I or II will undergo routine preoperative assessment by an anesthetist. Before surgery, patients will receive either intravenous dexamethasone (8 mg diluted in 100 mL normal saline) or 100 mL normal saline alone. The medication will be administered through a peripheral intravenous cannula.
Spinal anesthesia will then be performed using a standard technique. A 25-gauge spinal needle will be used to administer 12-15 mg of 0.75% hyperbaric bupivacaine into the lower lumbar region while the patient is in the sitting position. After confirming the flow of cerebrospinal fluid, the patient will be positioned for surgery.
The level and effectiveness of anesthesia will be assessed using standard sensory and motor assessments. Surgery will begin after an adequate level of numbness and motor block has been achieved. The recovery of sensory and motor function will subsequently be assessed at regular 15-minute intervals by an anesthesia team member who was not involved in administering the spinal anesthesia, to minimize assessment bias.
The main outcome will be the time required for the sensory block to regress from its initial level to the lower thoracic region (T10-T12). Additional outcomes will include the total duration of sensory and motor block and postoperative pain, assessed using a visual pain scale four hours after surgery.
Patient information such as age, sex, diagnosis, type of surgery, duration of sensory and motor block, and postoperative pain score will be recorded and analyzed to determine whether intravenous dexamethasone prolongs the duration of spinal anesthesia.
Detailed description
This study will evaluate the effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in patients undergoing lower abdominal surgery.
Eligible patients will be adults classified as American Society of Anesthesiologists (ASA) physical status I or II and meeting the predefined inclusion and exclusion criteria. All patients will undergo a preoperative assessment by a consultant anesthetist and will be deemed fit for anesthesia and surgery before enrollment.
After establishment of standard monitoring in the operating theatre, an 18-gauge peripheral intravenous cannula will be secured. Patients will receive either 8 mg of dexamethasone diluted in 100 mL of normal saline or 100 mL of normal saline alone, according to the study protocol. The administration will be performed in a manner intended to maintain blinding of the personnel responsible for subsequent assessment of block regression.
Following the intravenous intervention, spinal anesthesia will be performed using a 25-gauge spinal needle with the patient in the sitting position. A dose of 12-15 mg of 0.75% hyperbaric bupivacaine will be administered intrathecally at the L3-L4 or L4-L5 intervertebral space. Correct intrathecal placement will be confirmed by free flow of cerebrospinal fluid through the spinal needle. The patient will subsequently be positioned supine.
The sensory block will be assessed by testing the response to pinprick at the relevant dermatomes, while the degree of motor blockade will be assessed using the Modified Bromage Scale. Surgery will commence after an adequate sensory block extending to the T4 dermatome and a Modified Bromage score of 1 have been achieved.
Following establishment of spinal anesthesia, serial assessments of sensory and motor blockade will be performed at 15-minute intervals by a member of the anesthesia team who was not involved in administration of the spinal anesthetic, in order to minimize assessment bias. Sensory block regression will be assessed sequentially at the dermatomes from T4 toward the lower thoracic levels. The primary outcome will be the duration from establishment of the sensory block until regression to the T10-T12 dermatome level.
Following surgery, patients will be transferred to the Post-Anesthesia Care Unit (PACU), where continued assessment of the sensory and motor blockade will be performed. The total duration of sensory blockade and motor blockade will be recorded. Postoperative pain intensity will be assessed using the Visual Analogue Scale (VAS) at 4 hours after surgery.
The study will collect demographic and clinical variables, including age, sex, primary diagnosis, and type of surgical procedure. Quantitative outcome measures will include the time required for sensory block regression to the T10-T12 level, total duration of sensory blockade, total duration of motor blockade, and postoperative pain intensity at 4 hours. These outcomes will be compared to determine whether intravenous dexamethasone prolongs the duration of hyperbaric bupivacaine spinal anesthesia and influences postoperative analgesic outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Dexamethasone | Active comparator | Drug: Dexamethasone8mg of Dexamethasone in 100ml Normal Saline will be administered |
| Control group | Placebo comparator | Drug: PlaceboWill receive 100ml of normal saline |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing lower abdominal surgeries and orthopaedic surgeries including pelvic and lower extremity surgeries
- Patients classified as American Society of Anesthesiologists (ASA) physical status I or II
Key exclusion criteria (7 listed)
- Patients with a history of spinal surgery, spinal instrumentation, or previous failed spinal anaesthesia
- Patients with pre-existing neurological disorders, peripheral neuropathy, or sensory/motor deficits
- Patients with known hypersensitivity or allergy to local anaesthetic agents or dexamethasone
- Patients with congenital spinal deformities or acquired spinal conditions such as advanced spondylosis or kyphoscoliosis that may interfere with neuraxial block
- Patients with contraindications to spinal anaesthesia, including coagulopathy, local infection at the injection site, or raised intracranial pressure
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 |
|---|---|---|
| DexamethasoneWill receive 8mg of Dexamethasone in 100ml of Normal saline 10 minutes prior to induction of Anesthesia | Drug | Group Dexamethasone |
| PlaceboWill receive 100ml Normal saline 10 minutes prior to induction of spinal anesthesia | Drug | Control group |
Primary outcome
Time to Spinal Anesthesia regression
Time frame: From administration of spinal anesthesia until sensory block regresses by two dermatomes, assessed for up to 6 hours after spinal anesthesia
Time in minutes from administration of spinal anesthesia until sensory block regresses by two dermatomes from the maximum sensory block level.
Time in minutes from administration of spinal anesthesia until the patient first requests rescue analgesia.
Time frame: From administration of spinal anesthesia until the patient's first request for rescue analgesia, assessed for up to 6 hours after spinal anesthesia.
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 15 Sep 2026.
- Background: PubMed 37736711Abdel-Wahab AH, Abd Alla ES, Abd El-Azeem T. Effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in lower abdominal surgery, Randomized controlled trial. BMC Anesthesiol. 2023 Sep 22;23(1):323. doi: 10.1186/s12871-023-02282-y.
- Individual participant dataSharing planned: No. Not allowed by Ethical committee
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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.
Jawad Zaheer, MBBS, FCPS study chair
Head of Department of Anesthesiology
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 Dexamethasone and Spinal Anesthesia, run by Holy Family Hospital, Pakistan 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 7 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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?
Contact Tayyab Principal Investigator, MBBS (+92 308 5220273, tayyabmasood428@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Spinal Anesthesia regression (time frame: From administration of spinal anesthesia until sensory block regresses by two dermatomes, assessed for up to 6 hours after spinal anesthesia). 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?
On the ClinicalTrials.gov record for NCT07819682, 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 15 Sep 2026.