Optimal dose of dexmedetomidine as an adjuvant to ropivacaine 0.75% with dextrose 80mg used in spinal anesthesia in patients undergoing lower abdominal and lower limb surgeries

Phase 4

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2024/02/062187

Lead Sponsor: Vinayaka Missions Research Foundation

Brief Summary: Introduction:

Subarachnoid block is the most commonly performed block for lower abdominal, perineum and lower limb surgery. Many adjuncts like clonidine, fentanyl, ketamine, tramadol, neostigmine, magnesium sulphate, etc. have been used to prolong motor and sensory block, haemodynamic stability and reduced demand for rescue analgesics in first 24 hours. Dexmedetomidine is a more selective alpha 2 adrenoceptor agonist and has recently been widely used as an adjuvant to intrathecal local anaesthesia.

Advantages/benefits that would accrue out of the research: Intrathecal dexmedetomidine significantly prolongs analgesic effect thus reducing higher doses of local anaesthetic agents, Reduces the requirement of post-operative analgesic, Optimal dose of intrathecal dexmedetomidine prevents adverse effects such as hypotension and bradycardia which is most reported intraoperative and postoperative period

Study procedure:

After getting approval from the ethics and research committee, after applying inclusion and exclusion criteria, informed written consent is obtained, and patients are randomly divided into five groups. All patients received a drug volume of 3.2ml containing 3ml of hyperbaric ropivacaine hydrochloride (7.5mg/ml). The study groups received dexmedetomidine (available as 100mcg/1ml) 5mcg (group D1), 10mcg (group D2) and 15mcg (group D3) in an identical volume of 0.2ml, diluted with normal saline and added to ropivacaine in the same syringe. The control group (Group C) received 0.2ml of NS added to ropivacaine. Insulin syringe (1ml) was used for measuring fluids<1ml.

After arrival into the operation theatre, standard monitor was attached. ECG, pulse oximetry and non-invasive blood pressure were monitored and baseline values were recorded. An intravenous line was secured.

With the patient in sitting position, under all aseptic conditions, lumbar puncture was performed at L2-3 or L3-4 intervertebral space with 25G Quincke spinal needle until free flow of cerebrospinal fluid is seen. The drug is injected intrathecally using a 5ml Syringe.

Time of onset and duration of Motor blockage (using bromage scale), Time of onset and duration of Sensory blockage (using pin-prick method), Time to first rescue analgesia, Intra-operative systolic/diastolic blood pressure, heart rate are recorded.

In postoperative period, Patient vitals and pain score is recorded using VAS scale are recorded.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Patients scheduled for elective lower abdominal and lower limb surgeries under subarachnoid block in VMMCH, Karaikal.
1. Patients of American Society of Anaesthesiologists (ASA) physical status I and II.

Exclusion Criteria

Patients allergic to any of the drugs used 2) Patients having any absolute contraindications for spinal anesthesia such as patient not willing raised intracranial pressure, severe hypovolemia, bleeding diathesis, local infection and cardiac respiratory, and CNS diseases 3) Patients having hypertension 4) Patients with obesity more than 30kg per meter square 5) Patient with height less than 150cms.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare Total duration of analgesia and Post-operative analgesia of intrathecal dexmedetomidine as an adjuvant to hyperbaric ropivacaine in subarachnoid block in patients undergoing lower abdominal and lower limb surgeries	Time of drug given to 10th hour of postoperative period

Secondary Outcome Measures

Name	Time	Method
To compare	1)Onset of sensory blockade

Trial Locations

Locations (1): Vinayaka Missions Medical College and hospital
🇮🇳
Karaikal, PONDICHERRY, India
Vinayaka Missions Medical College and hospital
🇮🇳Karaikal, PONDICHERRY, India
Dr Abhisheak Raveendran
Principal investigator
9941078403
rabhisheak91@gmail.com