Effect of sitting for 1 minute versus lying down immediately after giving spinal anaesthesia on vital parameters like heart rate , blood pressure and oxygen saturation

Phase 4

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2024/07/070381
• Lead Sponsor: Dr Swathi Kamath

Brief Summary

After approval from the Institutional Ethics Committee, patients satisfying the inclusion criteria will be enrolled in the study. A thorough pre-anaesthetic evaluation will be done as per institutional protocol. Written informed consent will be taken after explaining the patients in detail regarding the study. All patients will be kept nil per oral and premedicated as per the institutional protocol. Patients will be shifted to the operation theatre. Standard monitors will be attached including electrocardiography, peripheral oxygen saturation and non-invasive blood pressure monitor. All the basal parameters will be recorded. All patients will be co-loaded with Ringer’s lactate solution 10 ml/kg body weight. Patients will be put in sitting position.

Those patients who received subarachnoid block under strict aseptic precautions through midline approach at L3-L4 interspinous space with 25 gauge Quincke-Babcock spinal needle using 3 ml of 0.75% heavy Ropivacaine administered at the rate of 0.2 ml/sec will be taken up for the study. The time of intrathecal drug injection will be noted as time “0†The patients who are made to lie down immediately after giving spinal anaesthesia will be considered as group A. The patients who are made to sit for 1 minute before positioning them supine after giving spinal anaesthesia will be considered as group B. The decision to position the patient after injection of the spinal drug will be of the consultant anaesthesiologist in charge. Sedation will be given as per the institutional protocol.

Following parameters will be assessed:

1.Onset of anaesthesia will be considered when loss of sensation is achieved at L1 dermatome level. Sensory block will be assessed by cold spirit swab method along midclavicular line bilaterally every 2 minutes until 10 minutes, there after every 5 minutes until 30 minutes. The highest dermatome showing sensory analgesia will be taken as the upper segmental level of the block when it remained the same even after 5 minutes. Sensory blockade at the time of shifting from operation theatre will be noted. Duration of sensory block will be considered as from the onset of the block till the patient complains of pain.

2.The motor block of both lower limbs will be assessed using the Modified Bromage Scale every 2 minutes before the onset of the surgery. Onset of motor blockade will be considered when the patient is not able to move feet or knees (modified Bromage grade 3 score). The duration of motor block will be taken as the time from full intensity motor blockade until a Modified Bromage grade 0 score is achieved.

3.Hemodynamic changes - The changes in heart rate, systolic and diastolic blood pressure and blood oxygen saturation will be recorded

a)every 2 min for first 20 min

b)there after every 5 min for 60 min

c)at 30 min intervals up to 300 min after subarachnoid block

â—Hypotension will be defined as a decrease to MAP< 65 mmHg, treated with IV bolus of 6 mg Inj. Ephedrine and 100 ml of Ringer lactate.

â—Bradycardia will be defined as HR < 40 beats/min and treated with Inj. Atropine 0.6 mg IV bolus.

â—Desaturation is defined as SpO2< 92% and treated with 6 L oxygen per minute.

4. Duration of anaesthesia will be assessed from the time of onset of the anaesthesia till the patient complains of pain postoperatively.

5.Any complications during the procedure will be noted.

(1)Inadequate spinal anaesthesia requiring either repeating the intrathecal drug, or converting to general anaesthesia

(2)Inadequate duration of anaesthesia requiring supplementation of analgesia

(3)Bradycardia and hypotension due to other reasons like blood loss.

(4)Nausea and vomiting

6.Number of times vasopressors, Inj. Ephedrine 6mg IV bolus and Inj. Atropine 0.6mg IV bolus given will be noted.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-04-07
• Study Start: 2024-07-15
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

ASA PS 1 and 2 Height 150-180 cm Patients undergoing lower limb surgeries under subarachnoid block.

Exclusion Criteria

1.Patient’s refusal 2.Patient who cannot comprehend, uncooperative patient 3.Pregnant women 4.Patient’s with any neurological deficits.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the hemodynamic changes in patients who remain in sitting position for 1 minute with the patients who are placed in supine position immediately after intrathecal injection of hyperbaric 0.75% Ropivacaine	12 hours

Secondary Outcome Measures

Name	Time	Method
To compare -	Onset of sensory and motor block

Trial Locations

Locations (1)

K. S. Hegde Medical Academy; 🇮🇳 Kannada, KARNATAKA, India

K. S. Hegde Medical Academy

🇮🇳Kannada, KARNATAKA, India

Dr Swathi Kamath

Principal investigator

9482070289

swathi.kamath310@gmail.com