To compare the effect of Fentanyl and Dexmedetomidine when added to bupivacaine in Spinal Anaesthesia

Not yet recruiting

• Conditions: Elective Gynaecological Surgeries

• Registration Number: CTRI/2013/06/003755
• Lead Sponsor: Govt Medical College Trivandrum

Brief Summary

**Dexmeditomedine** is an α-2 adreno receptor agonist, which is approved as an intravenous sedative and analgesic drug. It is a useful adjuvant in regional anesthesia. Kanazi et al, found that 5μg Dexmeditomedine and 50μg clonidine are equipotent intrathecally when added to Bupivacaine in patients undergoing major surgeries in the abdomen and lower extremities. Dexmeditomedine given intrathecally along with Bupivacaine produce significantly longer duration of sensory and motor block than Bupivacaine alone without serious side effects. It maintains patient arousability and respiratory function. Dexmeditomedine has a role in the field of critical care and it also facilitates easy weaning from mechanical ventilation.

 **Fentanyl** is a potent, synthetic [narcotic analgesic](http://en.wikipedia.org/wiki/Narcotic_analgesic "Narcotic analgesic") with a rapid onset and short duration of action. It is a strong agonist at the [μ-opioid](http://en.wikipedia.org/wiki/Mu_opioid_receptor "Mu opioid receptor") receptors. Historically it has been used to treat [breakthrough pain](http://en.wikipedia.org/wiki/Breakthrough_pain "Breakthrough pain") and is commonly used in pre-procedures as a pain reliever as well as an [anaesthetic](http://en.wikipedia.org/wiki/Anesthetic "Anesthetic") in combination with a [benzodiazepine](http://en.wikipedia.org/wiki/Benzodiazepine "Benzodiazepine"). Fentanyl is approximately 100 times more potent than [morphine](http://en.wikipedia.org/wiki/Morphine "Morphine"), with 100 micrograms of fentanyl approximately equivalent to 10 mg of morphine and 75 mg of [pethidine](http://en.wikipedia.org/wiki/Pethidine "Pethidine") (meperidine) in analgesic activity.It has an [LD50](http://en.wikipedia.org/wiki/Median_lethal_dose "Median lethal dose") of 3.1 milligrams per kilogram in rats, and an LD50 of 0.03 milligrams per kilogram in monkeys.

Gynaecological procedures including vaginal hysterectomy, recanalization, ovarian cystectomy  are often done under regional anesthesia. Surgery on the uterus and other genital organs performed under epidural or spinal block is often accompanied by visceral pain, nausea and vomiting. Fentanyl in various doses (10, 20, 30, 40 μg) when added to spinal Bupivacaine increase the duration of analgesia and reduce intraoperative nausea and vomiting. Dexmedetomidine is an α2- adrenoreceptor agonist that is approved as an intravenous sedative and coanalgesic drug. Its use is often associated a decrease in heart rate and blood pressure. Intrathecal and epidural characteristics of Dexmedetomidine were studied in animals. Most of the clinical studies about intrathecal α2 adrenoreceptor agonist are related to clonidine. There is little in the literature about the use of intrathecal Dexmedetomidine with local anaesthesia in humans. Kanazi *et al.*found that 3 μg Dexmedetomidine and 30 μg clonidine are equipotent intrathecally when added to bupivacaine in patients undergoing urology procedures. The same author found that Dexmedetomidine and Clonidine produced significant short onset of sensory and motor block as well as significantly longer duration of sensory and motor block than Bupivacaine alone without serious side effects. The aim of this study is to compare the effect of Dexmedetomidine 5μg versus fentanyl 25 μg on intraoperative analgesia and the duration of sensory motor block when added to 10 mg intrathecal plain bupvacaine.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-07
• Last Update Posted: 2013-04-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• ASA I / II / III of ASA physical status classification.
• Height 155 to 175 cm.

Exclusion Criteria

• Patients having drug allergy to local anaesthetics.
• Those with anatomical abnormalities of the spine, peripheral neuropathy, bleeding disorders or anticoagulation therapy.
• Patients with serious systemic illness, psychiatric illness, mental retardation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of analgesia in terms of time for onset of mild pain postoperatively visual analogue scale 4 and above or patient request for analgesia	Visual analogue scale assessed every 15 minutes till score reaches 4 and above or till the patient requests analgesia

Secondary Outcome Measures

Name	Time	Method
Peak sensory level reached	Intraoperative
Haemodynamic profile of the two groups	every minute for the first 20 minutes and every two-minute for the next 20 minutes and every five minutes till the end of surgery and then every 10-15 minutes for three hours post operatively
Need of additional analgesic	Intraoperative
• Incidence of complications including depression, nausea, vomiting, pruritus, hypotension, bradycardia, shivering between the two groups	Intraoperative and Postoperative
Time for onset of adequate level of analgesia ( T10 level assessed by bilateral pin prick )	Intraoperative
Time taken for motor block to recede to Bromage	Intraoperative and Postoperative
Sedation produced by the two groups	Intraoperative every 15 minutes

Trial Locations

Locations (1)

obstetric and gynaecology OT including pre and postoperative care room; 🇮🇳 Thiruvananthapuram, KERALA, India

obstetric and gynaecology OT including pre and postoperative care room

🇮🇳Thiruvananthapuram, KERALA, India

Dr Nikhil Nandan

Principal investigator

9895415212

nikhilnandan@gmail.com