Effect of drug given during spine surgery for old aged patients on Recovery and mentation

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/06/026077
• Lead Sponsor: Indraprastha Apollo Hospital New Delhi

Brief Summary

This study is aimed to see the ’’ **Effect of Intraoperative Dexmedetomidine infusion on Postopearative Cognitive Dysfunction and Recovery Quality in an Elderly Patient posted for Spine Surgery’’**

**Primary Outcome Variables:**

We will assess postoperative cognitive function and quality of recovery utilizing

1.    1.  Mini- Mental State Examination (MMSE) Scores.

2.     2.  15-item quality of recovery score (QoR15) questionnaire.

**Secondary Outcome Variables:**

1.     Intraoperative propofol consumption.

2.     Intraoperative and postoperative fentanyl requirement.

3.     Haemodynamic changes.

On the day of surgery, a baseline neurophysiological testing, using both MMSE (T0) and QoR15 (Q0) scoring would be done at 7:00 am. No sedative premedication will be prescribed. After adequate fasting, the patient will be shifted to the operating theatre where monitors such as electrocardiogram, pulse oximeter, and non-invasive blood pressure cuff will be applied and intravenous (IV) access secured. At this time computer generated randomization table will be used to assign each patient to either the dexmedetomidine group (Group D, n=30) or placebo group (Group P, n=30). A 50 ml syringe containing dexmedetomidine 4mcg/ml in normal saline for Group D or normal saline for Group P will be prepared shortly before induction anaesthesia by an anesthesiologist, who will be the part of study but not involved in the perioperative management of these patients. The study drug infusion will be started by the same anesthesiologist soon after the securing the IV access. Group D will receive IV dexmedetomidine at the rate of 0.5 mcg/kg/hr until beginning of skin closure. Group P will receive volume matched saline.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-24
• Study Completion: 2021-08-14
• Last Update Posted: 2021-08-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with American Society of Anesthesiologists (ASA) physical status I-III aged 60- 80 years old, undergoing elective lumbar spine surgery.

Exclusion Criteria

• 1.Patients age less than 60 years and more than 80 years old.
• 2.Patients with a pre-operative or intraoperative ECG (electrocardiogram) that showed severe bradycardia (sinus rhythm, heart rate less than 50/ min) or conduction block 3.Patients with associated renal, hepatic and respiratory dysfunction.
• 4.Patients with history of central nervous system disease such as head injury, stroke, previous neurosurgery, behavioral disturbances or mental retardation.
• 5.Patients with preoperative cognitive dysfunction (MMSE<24) 6.Patients on β-blockers, cimetidine, digoxin, α2-agonists, anticonvulsants or psychotropic medications 7.Patients with allergy to dexmedetomidine or another alpha-2 adrenergic receptor agonist.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Mini- Mental State Examination (MMSE) Scores.	1. Before Anaesthesia | 2. Day 1 of Surgery | 3. Day 2 of Surgery | 4. Day 3 of Surgery
2.15-item quality of recovery score (QoR15) questionnaire.	1. Before Anaesthesia | 2. Day 1 of Surgery | 3. Day 2 of Surgery | 4. Day 3 of Surgery

Secondary Outcome Measures

Name	Time	Method
1.Intraoperative propofol consumption.	2.Intraoperative and postoperative fentanyl requirement.

Trial Locations

Locations (1)

Indraprastha Apollo Hospital; 🇮🇳 South, DELHI, India

Indraprastha Apollo Hospital

🇮🇳South, DELHI, India

inderpreet singh walia

Principal investigator

9876624523

inderpreet.inderwalia@gmail.com