Clinical Trials Logo

Clinical Trial Summary

The purpose of the study is to compare the onset and duration of sensory and motor block after spinal anesthesia between intrathecal bupivacaine alone vs intrathecal bupivacaine and dexmedetomidine combination.


Clinical Trial Description

After approval from hospital ethical committee, parturient scheduled for elective Cesarean delivery falling in ASA II status, aged 18 - 45, with a BMI of 18-35kg/m2 will be allocated to either of the two groups B and D according to systemic randomized sampling technique, with every 3rd patient being enrolled in the study. The patients falling on odd numbers will be allocated group B and those falling on even numbers will be allocated group D. Written informed consent will be taken for enrollment in study. Performa questionnaire data will be collected by researcher herself (Annexure VII). All parturients will be premedicated with Tab Omeprazole 20mg at 6:00 hours with a sip of water. Two 18G IV cannulas will be maintained in Operation Theater (OT). All patients will be pre-hydrated with Lactated Ringer's solution at rate of 20ml/kg by OT staff. On arrival to operating room standard monitoring consisting of pulse-oximeter, non-invasive blood pressure (NIBP) and ECG will be attached and baseline readings checked and recorded. Intrathecal drugs will be prepared by the researcher herself. Patient's back will be prepared using aseptic measures, L3-L4 space will be identified and local anesthetic infiltrated. After 2 min 25 gauge pencil point spinal needle of B-Braun will be introduced. After obtaining free flow of CSF 2ml of 0.5% hyperbaric Bupivacaine 2 ml will be injected to Group B and 2ml of 0.5% bupivacaine mixed with 5µg dexmedetomidine will be injected in Group D, patient will be immediately placed in supine position. Timer will be started by the OT assistant as soon as the drug is injected. Spinal puncture will be performed by Trainee researcher herself who had experience of more than 200 spinal blocks. Data collection will be done by fellow colleague of equal experience. Sensory blockade will be tested using pinprick method with a blunt 27G hypodermic needle every 1 min till loss of sensation at xiphoid (T6 level). Quality of motor blockade will be assessed by modified Bromage scale (Annexure I) at 3 mins then every 1 min till Bromage I motor block is achieved. Intra-operative hypotension (decrease in mean BP of more than 20%) will be treated with 3 - 6 mg ephedrine and bradycardia (HR < 60bpm) will be treated with 0.4mg atropine. Post-operative analgesia will be assessed half hourly for the 1st 3 hours, then 1 hourly using visual analogue scale (0-10) till the time to 1st request for analgesics or VAS ≥ 4, whichever comes first. Injection tramadol 50mg and injection paracetamol 1g will be used as rescue analgesia. Injection paracetamol will be given 6 hourly after the first dose for 24 hours. Duration of motor block will also be assessed via the Bromage Score along with assessment of VAS score. Time to regaining of the full flexion of knees and hips will be recorded. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05469529
Study type Interventional
Source KRL Hospital, Islamabad
Contact Rida Qureshi
Phone +923189301930
Email ridaqureshi00@gmail.com
Status Recruiting
Phase N/A
Start date April 15, 2022
Completion date October 15, 2022

See also
  Status Clinical Trial Phase
Completed NCT04577430 - Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period N/A
Completed NCT03220880 - Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
Completed NCT05291364 - Dexmedetomidine in Splanchnic Nerve Neurolysis N/A
Recruiting NCT05249153 - Dexmedetomidine and Sufentanil Effect in PCA on Pediatric Patients Undergoing Scoliosis Surgery N/A
Completed NCT01688648 - Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft N/A
Completed NCT05103735 - Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Recruiting NCT06030804 - Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery N/A
Terminated NCT03253224 - Magnesium and Postoperative Pain Phase 4
Recruiting NCT06210061 - Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring N/A
Recruiting NCT05525819 - Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection N/A
Completed NCT04665453 - Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children N/A
Completed NCT06018948 - Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients Phase 4
Completed NCT03775655 - Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section Phase 2/Phase 3
Completed NCT03658421 - Dexmedetomidine as Adjuvant for FNB in TKA N/A
Completed NCT03234660 - Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia N/A
Completed NCT06020781 - Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block N/A
Recruiting NCT06207331 - Effects of Atomized Dexmedetomidine on Lung Function in Patients With Chronic Obstructive Pulmonary Disease N/A
Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
Completed NCT06098209 - Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker N/A
Not yet recruiting NCT06062550 - Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery Phase 4