Efficacy of Dexmedetomidine given through epidural space in improving oxygenation and shunt fraction in patients undergoing lung surgery via chest wall thoracotomy.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/11/005182
• Date of registration: 07-11-2014
• Prospective Registration: Yes
• Primary sponsor: Nizams institute of Medical Sciences
• Public title: Efficacy of Dexmedetomidine given through epidural space in improving oxygenation and shunt fraction in patients undergoing lung surgery via chest wall thoracotomy.
• Scientific title: Title-â??The Effect of Epidural dexmedetomidine on oxygenation and shunt fraction in patients undergoing thoracotomy and one lung ventilationâ??
• Date of first enrolment: 15-11-2014
• Target sample size: 60
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10299
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Dr Prachi Kar
• Affiliation: Nizams Institute of Medical Sciences

• Name: Dr Prachi Kar
• Affiliation: Nizams Institute of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: 18-60 yrs, ASA I-II patients undergoing Thoracotomy and one lung ventilation for lung surgery.
Exclusion criteria: Contraindication to Epidural anaesthesia, Known allergy to study drugs, Documented severe cardiovascular disease, H/o Myocardial infarction, arrhythmias, Hypertensives on treatment with alpha2 agonists, Severe neuropsychiatric disease, renal dysfunction(S.cr >1.5gm/dl), Hepatic dysfunction, Long term alcohol or other drug addiction.

Intraoperative exclusion criteria- If Spo2 decreased to < 92% at any point of time, Requirement of PEEP for maintaining oxygenation, Improper lung isolation, Significant bleed ( Hb < 8 despite transfusion), Failed Epidural, Haemodynamic fluctuations requiring use of Vasoactive drug.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: J00-J99- Diseases of the respiratory system Health Condition 2: null- Patients undergoing thoracotomy and one lung ventilation

Intervention(s)

Intervention1: RD group: In the Intervention group 1mcg/kg of Dexmedetomidine with 0.5% Ropivacaine in a volume of 7ml will be used for bolus epidural infusion
This will be followed by infusion of dexmedetomidine with Ropivacaine 0.5% @5ml/hr.This infusion will contain 0.2mcg/kg of dexmedetomidine in each 5ml of 0.5% of ropivacaine infusion.To simplify, for a 50kg man 0.2mcg/kg means 1omcg. so the infusion will be prepared in such a way that each 5ml of 0.5%Ropivacaine will contain 10mcg of dexmedetomidine. Since Ropivacaine is routinely used for epidural bolus and infusion , there is no mention of this drug in the Title.
Control Intervention1: RS group: In the comparator group, 0.5%Ropivacaine with saline(volume equivalent to 1mcg/kg of Dexmedetomidine) 7ml bolus followed by 5ml/hr of Ropivacaine(0.5% ) with saline(equivalent to 0.2mcg/kg of dexmedetomidine in a volume of 5ml).

Primary Outcome(s)

Oxygenation(PaO2) and shunt fraction(Qs/Qt)Timepoint: 15 minutes after two lung ventilation (TLV15)

15 and 45 minutes after one lung ventilation (OLV15, OLV45)

Reinstitution of TLV (ReTLV)

Secondary Outcome(s)

1.Induction dose of Propofol,

2.Heart rate, systolic, diastolic,Mean arterial pressure, Central venous pressure, Entropy values and End tidal sevoflurane concentrationTimepoint: 1.At induction

2. 1,2,5 minutes after intubation, TLV15, OLV15, OLV45, Re TLV

Secondary ID(s)

ED1/14

Source(s) of Monetary Support

Institution

Ethics review

Status: Approved
Approval date: 26/08/2014
Contact:

NIMS INSTITUTIONAL ETHICS COMMITTEE

Results

• Date Completed: 11/08/2015