To study the effect of intravenous dexamethasone on quality of recovery in patients undergoing caesarean section under spinal anaesthesia

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/07/009042
• Date of registration: 13-07-2017
• Prospective Registration: No
• Primary sponsor: Armed Forces Medical College
• Public title: To study the effect of intravenous dexamethasone on quality of recovery in patients undergoing caesarean section under spinal anaesthesia
• Scientific title: Effect of preoperative administration of intravenous dexamethasone on quality of recovery of patients undergoing caesarean section under spinal anaesthesia:A double blinded randomised controlled trialâ?? - NIL
• Date of first enrolment: 15-03-2017
• Target sample size: 60
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19420
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Random Number Table 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: Sqn Ldr Subhasish Patnaik
• Affiliation: Armed Forces Medical College

• Name: Sqn Ldr Subhasish Patnaik
• Affiliation: Armed Forces Medical College

Key inclusion & exclusion criteria

Inclusion criteria: 1)All ASA Physical Status I-II patients undergoing Lower Segment Caesarean Section under Spinal Anaesthesia

2)Written informed consent
Exclusion criteria: 1) Patients who are already on steroids

2) Sensitivity/Allergy to corticosteroids

3) Present /past history of Peptic Ulcer disease

4) Glaucoma

5) Diabetes mellitus type1/2

• Heart failure

• Fungal/viral systemic infection

• Hypertensive disorders

• Psychiatric illness



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Pregnant Females undergoing Lower Segment Caesarean Section Under Spinal Anaesthesia

Intervention(s)

Intervention1: Inj Dexamethasone IV: A Single shot of Inj Dexamethasone 2ml [8 mg] given intravenously prior to administartion of spinal anaesthesia,Quality of Recovery Score-40,a validated score will be taken after 24 hrs of surgery
Control Intervention1: Placebo: A Single Shot of Normal Saline 2ml IV given prior to administration of Spinal anaesthesia ,Quality of Recovery Score-40 will be measured 24 hrs after surgery

Primary Outcome(s)

To study the effect of single dose of dexamethasone IV on quality of recovery -40 score when given preoperatively in patients undergoing caesarean section under spinal anaesthesiaTimepoint: In Family Ward after 24 hrs of surgery

Secondary Outcome(s)

To study the effect of pre-op administration of dexamethasone on neonatal outcomes namely



a) NICU Admission

b) Need for respiratory support

c) Neonatal Sepsis



Timepoint: In Family Ward,NICU after 24hrs of surgery

Secondary ID(s)

NIL

Source(s) of Monetary Support

Dept Of Anaesthesiology and Critical Care,Armed Forces Medical College,Pune-Sholapur Road,Pune-411040

Ethics review

Status: Approved
Approval date: 16/11/2016
Contact:

Institutional Ethical Committee,AFMC,Pune