Anesthesia, Spinal, Bupivacaine, Hemodynamics, Orthopedic Procedures, Postoperative Recovery in Elderly Patients
Conditions
Keywords
Low-Dose Hyperbaric Bupivacaine, Standard-Dose Hyperbaric Bupivacaine, Spinal Anesthesia, Geriatric Anesthesia, Lower Limb Orthopedic Surgery, Hemodynamic Stability
Brief summary
The goal of this randomized controlled trial is to determine whether low-dose hyperbaric bupivacaine provides better hemodynamic stability and postoperative recovery compared with standard-dose hyperbaric bupivacaine in elderly patients undergoing lower limb orthopedic surgery under spinal anesthesia. The main questions it aims to answer are: * Does low-dose hyperbaric bupivacaine reduce the incidence of intraoperative hypotension and bradycardia compared with standard-dose hyperbaric bupivacaine? * Does low-dose hyperbaric bupivacaine improve postoperative recovery profile compared with standard-dose hyperbaric bupivacaine? Researchers will compare elderly patients receiving low-dose hyperbaric bupivacaine with those receiving standard-dose hyperbaric bupivacaine to determine whether a lower intrathecal dose improves cardiovascular stability and recovery without compromising the effectiveness of spinal anesthesia. Participants will: * Provide written informed consent before enrollment. * Undergo elective lower limb orthopedic surgery under spinal anesthesia. * Be randomly assigned to receive either low-dose or standard-dose hyperbaric bupivacaine. * Have their blood pressure, heart rate, and other vital signs monitored throughout the surgical procedure. * Be assessed for intraoperative hypotension and bradycardia according to predefined study criteria. * Be evaluated for postoperative recovery parameters, including motor recovery and readiness for postoperative recovery and mobilization. The information obtained from this study may help identify a safer and more effective spinal anesthetic technique for elderly patients undergoing orthopedic surgery.
Interventions
DRUGLow-Dose Hyperbaric Bupivacaine
Low-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.
DRUGStandard-Dose Hyperbaric Bupivacaine
Standard-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.
Sponsors
Mayo Hospital Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be unaware of the group allocation. Postoperative outcome assessment and data collection will be performed by an investigator blinded to treatment allocation. The anesthesiologist administering spinal anesthesia will not be blinded because of the preparation and administration of different doses of hyperbaric bupivacaine.
Intervention model description
Eligible participants will be randomized into two parallel groups. One group will receive low-dose hyperbaric bupivacaine and the other will receive standard-dose hyperbaric bupivacaine for spinal anesthesia. Outcomes related to hemodynamic stability and postoperative recovery will be compared between groups.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged 65 years and above. * Patients scheduled for elective lower limb orthopedic surgery under spinal anesthesia. * American Society of Anesthesiologists (ASA) physical status I-III. * Patients willing to participate and provide written informed consent.
Exclusion criteria
* Refusal to participate in the study. * Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy, severe hypovolemia, raised intracranial pressure). * Known hypersensitivity or allergy to bupivacaine. * Severe valvular heart disease. * Significant cardiac arrhythmias. * Uncontrolled hypertension. * Severe hepatic or renal impairment. * Pre-existing neurological disorders affecting lower limb motor or sensory function. * Severe spinal deformity or previous lumbar spine surgery interfering with spinal anesthesia. * Cognitive impairment or inability to provide informed consent. * Emergency orthopedic procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intraoperative Hypotension | From administration of spinal anesthesia until completion of surgery | Occurrence of intraoperative hypotension following spinal anesthesia, defined as a decrease in systolic blood pressure greater than 20% from baseline or systolic blood pressure less than 90 mmHg requiring intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intraoperative Bradycardia | From administration of spinal anesthesia until completion of surgery. | Occurrence of intraoperative bradycardia, defined as heart rate less than 50 beats per minute requiring pharmacological treatment. |
| Time to Complete Motor Recovery | From completion of surgery until achievement of Bromage Score 0, assessed up to 24 hours postoperatively | Time required to achieve complete motor recovery following spinal anesthesia, assessed using Bromage Score 0. |
| Time to First Ambulation | Within the first 24 hours after surgery | Time from completion of surgery to the patient's first assisted ambulation. |
| Postoperative Recovery Profile | From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively | Assessment of recovery following spinal anesthesia, including readiness for discharge from the post-anesthesia care unit and return of motor function. |
Countries
Pakistan
Contacts
CONTACTMuhammad Shaheryar Bashir, MBBS, BSc, FCPS (R) CHPE, DPHN
Outcome results
None listed