None listed
Conditions
Brief summary
Surgical patients who are illegible to Spinal Anesthesia and agree to participate in this study, will be enrolled into two different groups, the control group will receive spinal anesthesia with a fixed dose (FD group) of : (2.5 ml of 0.5% Hyperbaric Bupivacaine = 12.5 mg) + (25 micrograms of Fentanyl), while the cases group will receive a modifiable dose (MD group) for spinal anesthesia chosen according height and weight : (0.5% dose of hyperbaric Bupivacaine written in mls that matches the height and weight in Harten's chart) + ( 1 ml of 0.5% hyperbaric Bupivacaine “our modification") + ( 25 micrograms Fentanyl), after administering spinal anesthesia, assessment of vital signs (heart rate, Blood pressure), the sensory blockade level and duration, motor blockade adequacy and duration will take place to know which group achieved our primary and secondary outcomes.
Interventions
After securing informed consent, each patient will be allocated to either group: Arm 1 (Controls group with fixed dose of 0.5% Hyperbaric Bupivacaine (FD Group)), and Arm2: (Cases group with modified dose of 0.5% Hyperbaric Bupivacaine (MD Group)), using the two sides of a coin, where Head is for Arm1 and Tails for Arm2.
Arm 2 (MD Group): Spinal Anesthesia with dose of 0.5% hyperbaric Bupivacaine chosen accorded to height and weight following a modified Harten’s chart table + 25 micrograms of
After securing informed consent, each patient will be allocated to either group: Arm 1 (Controls group with fixed dose of 0.5% Hyperbaric Bupivacaine (FD Group)), and Arm2: (Cases group with modified dose of 0.5% Hyperbaric Bupivacaine (MD Group)), using the two sides of a coin, where Head is for Arm1 and Tails for Arm2. Arm 2 (MD Group): Spinal Anesthesia with dose of 0.5% hyperbaric Bupivacaine chosen accorded to height and weight following a modified Harten’s chart table + 25 micrograms of Fentanyl. - the dose administered will be: 0.5% Hyperbaric Bupivacaine according to Harten’s chart + 1 ml 0.5% Hyperbaric Bupivacaine + 25 micrograms Fentanyl, will be administered intrathecally immediately after placing the standard anesthesiology monitors (blood pressure cuff for blood pressure, pulse oximeter for heart rate and oxygen saturation) and before the operation room timeout for surgery. - the duration of administration: once before starting the surgery. - the mode of administration: intrathecally (Spinal Anesthesia). an experienced anesthesiologist will give spinal anaesthesia (injecting the previously mentioned mixture intrathecally) using a 25 G pencil point needle, at level of L2-L3 or L3-L4. The needle bevel must be directed upward during injection and rate of injection will be 0.2 ml per second. - the mode of delivery: face to face. - the number of times: once over 1 minute. - the location: in the operation room of a tertiary hospital: Prince Mohammed bin Abdulaziz Hospital in Riyadh Saudi Arabia. - To reduce complications : the chosen volume (dose) of intrathecal medications is within the known commonly used doses, and the patient's blood pressure, heart rate, Oxygen saturation will be monitored continuously (every five minutes) during and after spinal anesthesia.
Sponsors
Ministry of Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Patient age from 20 years of age to 55 years of age Male and female Surgical Procedures eligible for Spinal anesthesia.
Exclusion criteria
Patient Refusal Pediatrics History of Spine Surgery. Morbidly Obese ASA IV or more Central Nervous system disease Patient diagnosed with a condition that may affect the Capacity and normal physiology or anatomy of the BBB or intrathecal space hepatic dysfunction Patient who require > 2 trials of Spinal Anesthesia. Patient with contraindications to spinal anesthesia. Pregnancy epilepsy renal dysfunction Failed Spinal anesthesia and the need to convert to General anesthesia Surgeries that requires > 120 minutes Chronic pain Syndrome. Drug Addiction Allergy to Local Anesthetics
Outcome results
None listed