A trial to study the effect of two agents, Dexmedetomidine and midazolam for the control of pain occurring after surgery

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/06/004706
• Date of registration: 26-06-2014
• Prospective Registration: No
• Primary sponsor: SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES
• Public title: A trial to study the effect of two agents, Dexmedetomidine and midazolam for the control of pain occurring after surgery
• Scientific title: Comparison of the effects of addition of midazolam (or) dexmedetomidine versus placebo to intrathecal bupivacaine on post operative analgesia
• Date of first enrolment: 07-04-2014
• Target sample size: 90
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8945
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Aloka Samantaray
• Affiliation: Sri Venkateswara Institute of Medical Sciences

• Name: Aloka Samantaray
• Affiliation: Sri Venkateswara Institute of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: American Society of Anaesthesiologists physical status I/ II patients scheduled for elective endourological procedures under planned spinal anaesthesia were screened to participate. Patients were included if they are willing to participate in the study and able to understand and use numeric rating pain scale to evaluate their own pain intensity.
Exclusion criteria: Past history of spine surgery

Infection focus at back

Coagulopathy

Hypersensitivity to local anaesthetics or study drugs

On chronic analgesic therapy



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Scheduled for elective endourological procedures,perianal surgeries,inguinal hernia, and infra umbilical surgery under spinal anaesthesia

Intervention(s)

Intervention1: Dexmedetomidine-Bupivacaine: Dose:3ml of 0.5% hyperbaric bupivacaine combined with 5mcg of preservative free dexmedetomidine and made to a total volume of 3.5 mL
Frequency:Single
Route:Intrathecal space
Intervention2: Midazolam-Bupivacaine: Dose:3ml of 0.5% hyperbaric bupivacaine combined with 1mg of preservative free midazolam and made to a total volume of 3.5 mL
Frequency:Single
Route:Intrathecal space
Control Intervention1: Normal saline-Bupivacaine: Dose:3ml of 0.5% hyperbaric bupivacaine and 0.5 mL of saline 0.9%
frequency:Single
Route:Intrathecal space

Primary Outcome(s)

comparison of the duration of pain free post operative period(Time to first analgesic request) among Bupivacaine-Dexmedetomidine,Bupivacaine-Midazolam and Bupivacaine-Normal saline group.Timepoint: The numeric rating scale was used to assess pain at 0,2, 4, 6, 8, 12, and 24th hours of the postoperative period.

Secondary Outcome(s)

Nausea and vomiting, headache, and urinary dysfunctionTimepoint: Upto 24 hours after surgery

Ramsay sedation score (1: anxious, agitated and restlessness, 2: oriented and cooperative, 3: responds to command only, 4: brisk response to loud voice and light glabellar tap, 5: sluggish to no response to light glabellar tap or loud auditory stimulus, 6: no response even to painTimepoint: 15min,45minute after spinal anaesthesia and at the end of the surgery

hypotension, bradycardia, respiratory depression (respiratory rate 8 per minunte)Timepoint: Intraoperative period

0,2, 4, 6, 8, 12, and 24th hours of the postoperative period.

Secondary ID(s)

NIL

Source(s) of Monetary Support

SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES

Ethics review

Status: Approved
Approval date: 23/05/2011
Contact:

Institute Ethic Comittee