Geriatric PopulationNCT07363941
HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC DOSING IN GERIATRIC PATIENTS
A study testing Group A : Spinal Anaesthetic Dose and Group B : Conventional Dose in people with Geriatric Population and Spinal Anesthesia Induced Hypotension, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to find out whether height-based dosing of spinal anaesthesia provides better hemodynamic stability and anesthetic outcome than conventional fixed dosing in elderly patients undergoing lower limb orthopaedic surgery.The main questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Geriatric Population, Spinal Anesthesia Induced Hypotension, Spinal Anesthesia in Elderly Patients
- What is being tested?
- Group A : Spinal Anaesthetic Dose and Group B : Conventional Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jan 2026to 4 May 2026
- Phase
- Interventional
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 60 to 80 years. Either gender (male or female). Patients who are ASA physical status I-III. Individuals scheduled to undergo elective lower limb orthopaedic surgeries (e.g., fracture fixation, total knee replacement, open reduction and internal fixation).
- Patients planned to receive spinal anaesthesia as the primary anaesthetic technique.
- Those who provide informed written consent for participation in the study.
Who cannot join
- Individuals exhibiting a stature inferior to 150 cm. Patients receiving anti-hypertensive drugs or those on beta blockers or beta-agonists.
- Patients with a history of neurological disease like CVA or Parkinsonism. Patients presenting with sepsis (≥ 2 positive SIRS criteria with positive aseptically obtained blood or wound culture).
- Patients with a history of coagulation disorders like haemophilia or vWD or those with a history of anti-platelet drug intake in the last 2 weeks.
- Individuals possessing a documented history of hypersensitivity reactions to pharmacological agents utilized in the research.
- Patients who will be diagnosed with a skin infection at the spinal needle puncture site.
- Patients undergoing emergency orthopaedic procedures requiring immediate intervention
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
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
Karachi, Sindh, 74600
Dr Sidra Javed Consultant Anesthetist, MBBS, FCPS, PAIN FELLOW, +923332474831, sidra_dow@yahoo.com
Dr Mirza Shahzad Baig Consultant Anesthetist, MBBS, MCPS, FCPS, +923346441539, drshahzadbaig@hotmail.com
About this study
Official title: COMPARISON OF HEMODYNAMIC AND ANAESTHETIC OUTCOMES BETWEEN HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC DOSING IN GERIATRIC PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES
The goal of this clinical trial is to find out whether height-based dosing of spinal anaesthesia provides better hemodynamic stability and anesthetic outcome than conventional fixed dosing in elderly patients undergoing lower limb orthopaedic surgery.The main questions this study aims to answer are:
- Does height-based spinal anaesthetic dosing reduce the risk of hypotension and bradycardia during surgery as compared to conventional fixed dosing?
- Does it improve anaesthetic outcomes, such as the onset and duration of sensory and motor block?
Read the detailed description
Data collection would begin after the approval of ethical review committee of the institution. This investigation will encompass patients who are scheduled to undergo lower limb orthopaedic surgical procedures within the Department of Anaesthesia, SMBBIT, Karachi. Following a comprehensive description of the study and their acceptance to participate (written consent), the subject will be recruited as detailed in the inclusion criteria.
Data will be collected using a defined data collection proforma to record baseline demographics and clinical characteristics including age, height, gender, and residential status. Height will be measured in the supine position as the patients will be undergoing lower limb surgeries. The patient will be placed flat on a firm examination table or operating-room bed without a pillow, with legs extended and neutral. To accurately measure height in centimetres, a measuring tape or stadiometer will be placed along the length of the patient's body from the heel to the vertex of the head, using trained staff to ensure precise placement, and the reading will be recorded to the nearest decimal point.
The subjects will be allocated to one of two groups through a computer-generated random number sequence with concealed allocation to mitigate selection bias and safeguard the integrity of the randomization process. Allocation concealment will be accomplished by the Sequentially Numbered, Opaque, Sealed Envelope (SNOSE) method, conducted by a blinded independent researcher not involved in subject recruitment, surgical procedure, or clinical assessment. In the operating room, baseline pulse rate and mean arterial pressure will be measured before spinal anaesthesia is induced. Intravenous access will be established, and patients will be preloaded with Ringer Lactate (10 ml/kg) prior to induction of spinal anaesthesia.
Spinal anaesthesia will be provided in the sitting position, aseptically at the level of L3-4 vertebra. Group A will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally, whereas patients in Group B will be administered 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone. Subsequent to the administration of spinal anaesthesia, patients will be positioned in the supine orientation; sensory blockade will be evaluated utilizing the pinprick method with a blunt-tipped 23-gauge needle at the T10 dermatome level, while motor blockade will be assessed employing the Bromage scale. The specific time at which the most effective sensory and motor blockade is achieved will be documented in accordance with the established operational definition.
The hemodynamic (heart rate and mean arterial pressure) will be continuously monitored. The procedure and the principal investigator (in consultation with a faculty consultant with >5 years' experience) will mark the findings of "bradycardia" and "hypotension" based on the operational definition on the proforma. The early postoperative period will be followed in all patients in order to know sensory and motor blockade duration by operational definition, and each result will be written. The principal investigator will record collected data on a predesigned proforma. Confidentiality will be ensured along with data security measures allowing only authorized personnel access to all information. The study is produced to be directly relevant with its aims, and rigorous exclusion criteria will be used in minimizing potential biases or confounders.
Data will be entered into a secure database and analyzed using SPSS version 26. Continuous variables (including age, height, weight, BMI, heart rate, mean arterial pressure, onset of sensory block, and duration of sensory block) will be summarized as mean ± standard deviation or median with interquartile range, as appropriate. Comparisons between the two study groups will be performed using the independent sample t-test for continuous variables. Chi-square test or Fisher's exact test will be used for categorical variables, depending on expected cell counts. A p-value ≤ 0.05 will be considered statistically significant.
- Conditions
- Geriatric Population, Spinal Anesthesia Induced Hypotension, Spinal Anesthesia in Elderly Patients
- Being tested
- Group A : Spinal Anaesthetic Dose, Group B : Conventional Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A : Spinal Anaesthetic DoseDrug
Participants will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally
Group B : Conventional DoseDrug
Participants will receive 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone intrathecally
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally Receives: Drug: Group A : Spinal Anaesthetic Dose |
| Group B | Active comparator | Participants will recieve 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally Receives: Drug: Group B : Conventional Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
HYPOTENSION
Defined as a decrease of ≥20% in mean arterial pressure (MAP) from baseline or an absolute MAP <65 mmHg at any point during surgery, recorded using non-invasive blood pressure monitoring at five-minute intervals
Measured: Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade
BRADYCARDIA
It will be defined in terms of a heart rate of ≤ 60 beats/minute during surgery
Measured: Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade
ONSET OF SENSORY BLOCK
It will be defined as the time interval (in minutes) from the completion of intrathecal injection of bupivacaine to the loss of pinprick sensation at the T10 dermatome. The assessment will be carried out using a sterile blunt 23-gauge needle at one-minute intervals until loss of sensation is confirmed.
Measured: Subsequent to the administration of spinal anaesthesia till the attainment of sensory blockade
DURATION OF SENSORY BLOCK
It will be defined as the time interval (in minutes) from the onset of sensory block at the T10 dermatome (confirmed by loss of pinprick sensation) to the reappearance of sensation at the same dermatome level. The response will be assessed every 5 minutes using a sterile blunt 23-gauge needle.
Measured: Subsequent to the administration of spinal anaesthesia till the end of sensory blockade
ONSET OF MOTOR BLOCK
It will be defined as the time duration (in minutes) between the completion of intrathecal administration of bupivacaine until the patient develops Bromage III
Measured: Subsequent to the administration of spinal anaesthesia till the attainment of motor blockade
DURATION OF MOTOR BLOCK
The duration of motor block is defined as the time duration (in minutes) from the onset of motor block (inability to move feet) until the patient regains the ability to voluntarily move both feet.
Measured: Subsequent to the administration of spinal anaesthesia till the end of motor blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start3 Jan 2026
- Primary completion3 May 2026 (estimated)
- Study completion4 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Geriatric PopulationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally, whereas patients in Group B will be administered 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jehanzaib Muhammad Azam, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363941
- Sponsor's protocol ID
- IRB-000210/SMBBIT/Approval/20
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient Confidentiality: Sharing IPD could compromise patient confidentiality and anonymity. Informed consent: Participants are not providing informed consent for their data to be shared and it could raise ethical concerns.
Publications
Hasan SH. Randomized controlled trial on the effects of fixed-dose versus height-adjusted dose of hyperbaric bupivacaine used in spinal anaesthesia for cesarean section. J Nat Sc Biol Med. 2024;15(2):192-201.
Alkonaiesy RM, Amin SM, Abdallah NM, Muhammad SI, Hassan H. Effect of height-based spinal anaesthetic dose versus conventional dose on hemodynamics in lower limb surgeries in geriatric patients: a randomized controlled trial. Anaesth Pain Intensive Care. 2023;27(4):565-72.
Nazli B, Oguzalp H, Horasanli E, Gamli M, Dikmen B, Gogus N. The effects on sensorial block, motor block, and haemodynamics of levobupivacaine at different temperatures applied in the subarachnoid space. Biomed Res Int. 2014;2014:132687. doi: 10.1155/2014/132687. Epub 2014 Mar 18.
PubMed 24772412Messina A, La Via L, Milani A, Savi M, Calabro L, Sanfilippo F, Negri K, Castellani G, Cammarota G, Robba C, Morenghi E, Astuto M, Cecconi M. Spinal anesthesia and hypotensive events in hip fracture surgical repair in elderly patients: a meta-analysis. J Anesth Analg Crit Care. 2022 May 8;2(1):19. doi: 10.1186/s44158-022-00047-6.
PubMed 37386657Visavakul O, Leurcharusmee P, Pipanmekaporn T, Khorana J, Patumanond J, Phinyo P. Effective Dose Range of Intrathecal Isobaric Bupivacaine to Achieve T5-T10 Sensory Block Heights for Elderly and Overweight Patients: An Observational Study. Medicina (Kaunas). 2023 Mar 1;59(3):484. doi: 10.3390/medicina59030484.
PubMed 36984485Al Harbi MK, Alshaghroud SM, Aljahdali MM, Ghorab FA, Baba F, Al Dosary R, Bahadeq M. Regional anesthesia for geriatric population. Saudi J Anaesth. 2023 Oct-Dec;17(4):523-532. doi: 10.4103/sja.sja_424_23. Epub 2023 Aug 18.
PubMed 37779559Lim BG, Lee IO. Anesthetic management of geriatric patients. Korean J Anesthesiol. 2020 Feb;73(1):8-29. doi: 10.4097/kja.19391. Epub 2019 Oct 22.
PubMed 31636241Neuman MD, Feng R, Carson JL, Gaskins LJ, Dillane D, Sessler DI, Sieber F, Magaziner J, Marcantonio ER, Mehta S, Menio D, Ayad S, Stone T, Papp S, Schwenk ES, Elkassabany N, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes RA, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Giska M, Ranganath Y, Tedore T, Choi S, Li J, Kwofie MK, Nader A, Sanders RD, Allen BFS, Vlassakov K, Kates S, Fleisher LA, Dattilo J, Tierney A, Stephens-Shields AJ, Ellenberg SS; REGAIN Investigators. Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults. N Engl J Med. 2021 Nov 25;385(22):2025-2035. doi: 10.1056/NEJMoa2113514. Epub 2021 Oct 9.
PubMed 34623788
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF HEMODYNAMIC AND ANAESTHETIC OUTCOMES BETWEEN HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC DOSING IN GERIATRIC PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES
- ClinicalTrials.gov ID
- NCT07363941
- Acronym / sponsor ID
- IRB-000210/SMBBIT/Approval/20
- Conditions
- Geriatric Population, Spinal Anesthesia Induced Hypotension, Spinal Anesthesia in Elderly Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 3 May 2026 (estimated)
- Study completion
- 4 May 2026 (estimated)
- First posted
- 23 Jan 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.
The goal of this clinical trial is to find out whether height-based dosing of spinal anaesthesia provides better hemodynamic stability and anesthetic outcome than conventional fixed dosing in elderly patients undergoing lower limb orthopaedic surgery.The main questions this study aims to answer are:
- Does height-based spinal anaesthetic dosing reduce the risk of hypotension and bradycardia during surgery as compared to conventional fixed dosing?
- Does it improve anaesthetic outcomes, such as the onset and duration of sensory and motor block?
Detailed description
Data collection would begin after the approval of ethical review committee of the institution. This investigation will encompass patients who are scheduled to undergo lower limb orthopaedic surgical procedures within the Department of Anaesthesia, SMBBIT, Karachi. Following a comprehensive description of the study and their acceptance to participate (written consent), the subject will be recruited as detailed in the inclusion criteria.
Data will be collected using a defined data collection proforma to record baseline demographics and clinical characteristics including age, height, gender, and residential status. Height will be measured in the supine position as the patients will be undergoing lower limb surgeries. The patient will be placed flat on a firm examination table or operating-room bed without a pillow, with legs extended and neutral. To accurately measure height in centimetres, a measuring tape or stadiometer will be placed along the length of the patient's body from the heel to the vertex of the head, using trained staff to ensure precise placement, and the reading will be recorded to the nearest decimal point.
The subjects will be allocated to one of two groups through a computer-generated random number sequence with concealed allocation to mitigate selection bias and safeguard the integrity of the randomization process. Allocation concealment will be accomplished by the Sequentially Numbered, Opaque, Sealed Envelope (SNOSE) method, conducted by a blinded independent researcher not involved in subject recruitment, surgical procedure, or clinical assessment. In the operating room, baseline pulse rate and mean arterial pressure will be measured before spinal anaesthesia is induced. Intravenous access will be established, and patients will be preloaded with Ringer Lactate (10 ml/kg) prior to induction of spinal anaesthesia.
Spinal anaesthesia will be provided in the sitting position, aseptically at the level of L3-4 vertebra. Group A will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally, whereas patients in Group B will be administered 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone. Subsequent to the administration of spinal anaesthesia, patients will be positioned in the supine orientation; sensory blockade will be evaluated utilizing the pinprick method with a blunt-tipped 23-gauge needle at the T10 dermatome level, while motor blockade will be assessed employing the Bromage scale. The specific time at which the most effective sensory and motor blockade is achieved will be documented in accordance with the established operational definition.
The hemodynamic (heart rate and mean arterial pressure) will be continuously monitored. The procedure and the principal investigator (in consultation with a faculty consultant with >5 years' experience) will mark the findings of "bradycardia" and "hypotension" based on the operational definition on the proforma. The early postoperative period will be followed in all patients in order to know sensory and motor blockade duration by operational definition, and each result will be written. The principal investigator will record collected data on a predesigned proforma. Confidentiality will be ensured along with data security measures allowing only authorized personnel access to all information. The study is produced to be directly relevant with its aims, and rigorous exclusion criteria will be used in minimizing potential biases or confounders.
Data will be entered into a secure database and analyzed using SPSS version 26. Continuous variables (including age, height, weight, BMI, heart rate, mean arterial pressure, onset of sensory block, and duration of sensory block) will be summarized as mean ± standard deviation or median with interquartile range, as appropriate. Comparisons between the two study groups will be performed using the independent sample t-test for continuous variables. Chi-square test or Fisher's exact test will be used for categorical variables, depending on expected cell counts. A p-value ≤ 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group A will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally, whereas patients in Group B will be administered 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Group A : Spinal Anaesthetic DoseParticipants will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally |
| Group B | Active comparator | Drug: Group B : Conventional DoseParticipants will recieve 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 60 to 80 years. Either gender (male or female). Patients who are ASA physical status I-III. Individuals scheduled to undergo elective lower limb orthopaedic surgeries (e.g., fracture fixation, total knee replacement, open reduction and internal fixation).
- Patients planned to receive spinal anaesthesia as the primary anaesthetic technique.
- Those who provide informed written consent for participation in the study.
Key exclusion criteria (6 listed)
- Individuals exhibiting a stature inferior to 150 cm. Patients receiving anti-hypertensive drugs or those on beta blockers or beta-agonists.
- Patients with a history of neurological disease like CVA or Parkinsonism. Patients presenting with sepsis (≥ 2 positive SIRS criteria with positive aseptically obtained blood or wound culture).
- Patients with a history of coagulation disorders like haemophilia or vWD or those with a history of anti-platelet drug intake in the last 2 weeks.
- Individuals possessing a documented history of hypersensitivity reactions to pharmacological agents utilized in the research.
- Patients who will be diagnosed with a skin infection at the spinal needle puncture site.
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 |
|---|---|---|
| Group A : Spinal Anaesthetic DoseParticipants will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally | Drug | Group A |
| Group B : Conventional DoseParticipants will receive 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone intrathecally | Drug | Group B |
Primary outcome
HYPOTENSION
Time frame: Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade
Defined as a decrease of ≥20% in mean arterial pressure (MAP) from baseline or an absolute MAP <65 mmHg at any point during surgery, recorded using non-invasive blood pressure monitoring at five-minute intervals
BRADYCARDIA
Time frame: Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade
It will be defined in terms of a heart rate of ≤ 60 beats/minute during surgery
ONSET OF SENSORY BLOCK
Time frame: Subsequent to the administration of spinal anaesthesia till the attainment of sensory blockade
It will be defined as the time interval (in minutes) from the completion of intrathecal injection of bupivacaine to the loss of pinprick sensation at the T10 dermatome. The assessment will be carried out using a sterile blunt 23-gauge needle at one-minute intervals until loss of sensation is confirmed.
DURATION OF SENSORY BLOCK
Time frame: Subsequent to the administration of spinal anaesthesia till the end of sensory blockade
It will be defined as the time interval (in minutes) from the onset of sensory block at the T10 dermatome (confirmed by loss of pinprick sensation) to the reappearance of sensation at the same dermatome level. The response will be assessed every 5 minutes using a sterile blunt 23-gauge needle.
ONSET OF MOTOR BLOCK
Time frame: Subsequent to the administration of spinal anaesthesia till the attainment of motor blockade
It will be defined as the time duration (in minutes) between the completion of intrathecal administration of bupivacaine until the patient develops Bromage III
DURATION OF MOTOR BLOCK
Time frame: Subsequent to the administration of spinal anaesthesia till the end of motor blockade
The duration of motor block is defined as the time duration (in minutes) from the onset of motor block (inability to move feet) until the patient regains the ability to voluntarily move both feet.
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 23 Jan 2026.
- BackgroundHasan SH. Randomized controlled trial on the effects of fixed-dose versus height-adjusted dose of hyperbaric bupivacaine used in spinal anaesthesia for cesarean section. J Nat Sc Biol Med. 2024;15(2):192-201.
- BackgroundAlkonaiesy RM, Amin SM, Abdallah NM, Muhammad SI, Hassan H. Effect of height-based spinal anaesthetic dose versus conventional dose on hemodynamics in lower limb surgeries in geriatric patients: a randomized controlled trial. Anaesth Pain Intensive Care. 2023;27(4):565-72.
- Background: PubMed 24772412Nazli B, Oguzalp H, Horasanli E, Gamli M, Dikmen B, Gogus N. The effects on sensorial block, motor block, and haemodynamics of levobupivacaine at different temperatures applied in the subarachnoid space. Biomed Res Int. 2014;2014:132687. doi: 10.1155/2014/132687. Epub 2014 Mar 18.
- Background: PubMed 37386657Messina A, La Via L, Milani A, Savi M, Calabro L, Sanfilippo F, Negri K, Castellani G, Cammarota G, Robba C, Morenghi E, Astuto M, Cecconi M. Spinal anesthesia and hypotensive events in hip fracture surgical repair in elderly patients: a meta-analysis. J Anesth Analg Crit Care. 2022 May 8;2(1):19. doi: 10.1186/s44158-022-00047-6.
- Background: PubMed 36984485Visavakul O, Leurcharusmee P, Pipanmekaporn T, Khorana J, Patumanond J, Phinyo P. Effective Dose Range of Intrathecal Isobaric Bupivacaine to Achieve T5-T10 Sensory Block Heights for Elderly and Overweight Patients: An Observational Study. Medicina (Kaunas). 2023 Mar 1;59(3):484. doi: 10.3390/medicina59030484.
- Background: PubMed 37779559Al Harbi MK, Alshaghroud SM, Aljahdali MM, Ghorab FA, Baba F, Al Dosary R, Bahadeq M. Regional anesthesia for geriatric population. Saudi J Anaesth. 2023 Oct-Dec;17(4):523-532. doi: 10.4103/sja.sja_424_23. Epub 2023 Aug 18.
- Background: PubMed 31636241Lim BG, Lee IO. Anesthetic management of geriatric patients. Korean J Anesthesiol. 2020 Feb;73(1):8-29. doi: 10.4097/kja.19391. Epub 2019 Oct 22.
- Background: PubMed 34623788Neuman MD, Feng R, Carson JL, Gaskins LJ, Dillane D, Sessler DI, Sieber F, Magaziner J, Marcantonio ER, Mehta S, Menio D, Ayad S, Stone T, Papp S, Schwenk ES, Elkassabany N, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes RA, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Giska M, Ranganath Y, Tedore T, Choi S, Li J, Kwofie MK, Nader A, Sanders RD, Allen BFS, Vlassakov K, Kates S, Fleisher LA, Dattilo J, Tierney A, Stephens-Shields AJ, Ellenberg SS; REGAIN Investigators. Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults. N Engl J Med. 2021 Nov 25;385(22):2025-2035. doi: 10.1056/NEJMoa2113514. Epub 2021 Oct 9.
- Individual participant dataSharing planned: No. Patient Confidentiality: Sharing IPD could compromise patient confidentiality and anonymity. Informed consent: Participants are not providing informed consent for their data to be shared and it could raise ethical concerns.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A : Spinal Anaesthetic Dose and Group B : Conventional Dose in people with Geriatric Population and Spinal Anesthesia Induced Hypotension, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma 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 3 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: looking for participants now, as of the sponsor's last update on 23 Jan 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. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HYPOTENSION (time frame: Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade). The study lists 6 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 NCT07363941, which also lists 8 linked publications.
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 23 Jan 2026.