| CTRI Number |
CTRI/2026/01/100314 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess confusion and restlessness after general anaesthesia with sevoflurane in adults. |
|
Scientific Title of Study
|
Evaluation of incidence of sevoflurane induced emergence delirium following general anaesthesia in adults- An observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAVIYA T |
| Designation |
POSTGRADUATE M.D ANAESTHESIOLOGY |
| Affiliation |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
| Address |
FLAT NO.2C, ISHA CODE FIELD APARTMENT, PUTHUPAKKAM
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
09566242715 |
| Fax |
|
| Email |
kavisdoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAY NARAYANAN S |
| Designation |
PROFESSOR |
| Affiliation |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
| Address |
PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY, CHETTINAD HOSPITAL AND RESARCH INSTITUTE, CHETTINAD HEALTH CITY (OMR), KELAMBAKKAM
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7904535573 |
| Fax |
|
| Email |
vijaynarayanans@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR VIJAY NARAYANAN S |
| Designation |
PROFESSOR |
| Affiliation |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
| Address |
PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY, CHETTINAD HOSPITAL AND RESARCH INSTITUTE, CHETTINAD HEALTH CITY (OMR), KELAMBAKKAM
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7904535573 |
| Fax |
|
| Email |
vijaynarayanans@care.edu.in |
|
|
Source of Monetary or Material Support
|
| CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
|
|
Primary Sponsor
|
| Name |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Chettinad hospital and research institute , chettinad health city, Rajiv gandhi salai, Kelambakkam, chennai, Tamilnadu, India-603103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR KAVIYA T |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
D-Block,1st floor, Department of Anesthesiology, chettinad health city, rajiv gandhi salai, kelambakkam
Kancheepuram
TAMIL NADU |
09566242715
kavisdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research (CARE IHEC-I)( |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SEVOFLURANE |
No comparator agent (single arm observational study) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Posted for general anesthesia
2.Only elective cases
3.Duration of surgery more than 2hours. |
|
| ExclusionCriteria |
| Details |
1.Patients known to have preexisting diseases such as history of chronic dementia psychosis mental retardation cerebrovascular accidents with residual cognitive impairment.
2.Neurological surgeries
3.Psychiatric conditions
4.Pregnancy
5.Emergency surgery
6.Patients with BMI more than 35
7.Patient refusal. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine incidence of emergence delirium with sevoflurane in adults. |
150 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify factors associated with emergence delirium with sevoflurane in adults in perioperative period following general anesthesia |
150mins |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Delirium is
a disturbance of consciousness with inattention accompanied by change in
cognition or perceptual disturbance that develops over a short period and
fluctuates over time. Delirium during postoperative period can be
divided into Emergence delirium and Postoperative delirium based on its onset. Emergence delirium or Emergence agitation or Postanesthetic
excitement occurs during immediate postoperative period and lasting for
5-15mins. Emergence delirium is a clinical condition in which patients are awake
but experience alterations in disorientation and other mental status changes
that ranges from confusion and lethargy to violent and harmful behaviour. Emergence
delirium during immediate post anesthesia period is common. It may lead to
serious consequences for the patients such as injury, increased pain, hemorrhage,
self Extubation, removal of catheters, and it can necessitate physically or
chemically restraining the patients. Sevoflurane is an inhalational anesthetic used widely as outpatient
anesthesia due to its excellent hemodynamic stability and low blood solubility,
which allows rapid induction and emergence from general anesthesia, as well as
control of depth of anesthesia. How ever sevoflurane is associated
with higher incidence of emergence agitation in children. The rapid
removal of residual anesthetics due to low blood solubility of sevoflurane has
been suggested to cause emergence delirium in some patients. To
determine incidence and risk factors of emergence delirium in adults following
general anesthesia. Primary objective- Incidence of emergence
delirium with sevoflurane in adults. Secondary objective - To identify
factors associated with emergence delirium in perioperative period. A
prospective observational study to be conducted over 1 year where procedures in
specialities including general surgeries, Ent, Gynecological surgeries are
performed. Informed consent will be obtained preoperatively. Detailed history
and physical examination , baseline data like heart rate, blood pressure and
basic investigations will be collected. An iv access with 18Giv cannula will be
secured for all the patients. Premedication such as tab. Ranitidine 150mg and
tab. Alprazolam 0.5mg given night before surgery and 6am on day of surgery. After
shifting the patient inside OT, proper standard monitoring of spo2, NIBP, ECG,
Etco2 will be established and baseline variable values will be noted before the
procedure. Patient will be premedicated with inj. midazolam 0.02mg/kg iv , inj.
Glycopyrolate 0.01mg/kg iv, inj. fentanyl 2mcg/kg iv then an inducing agent
inj. propofol 2mg/kg iv followed by muscle relaxant inj. vecuronium 0.08mg /kg
iv along with inhalational agent sevoflurane. Patient lung were ventilated using
100% oxygen to maintain etco2 from 35 to 45mmhg. Tracheal intubation will then
be performed approximately 3mins after anesthesia induction by trained an anesthetist.
Tracheal intubation will be done with direct laryngoscope using macintosh blade
with appropriate size ET tube. ET tube will be secured at angle of mouth and et
tube position confirmed with 5point auscultation method. Then pt connected to
mechanical ventilator. After tracheal intubation urinary catheters were
inserted in all the patients. Plane of anesthesia is maintained throughout with
inhalational agent sevoflurane at 1-2%. In all patient muscle relaxation was
maintained with inj. vecuronium 0.1mg/kg iv. At the conclusion of procedure, the
inhaled agents were discontinued and the fresh gas flow was maintained with 6L
of oxygen. Patient given adequate analgesics. By the end of procedure Extubation
done with reversal agent inj. Myopyrolate iv according to patient requirement. ET
tube was removed when tidal volume >5ml/kg
, respiratory rate >12 cpm, the swallowing and cough reflex were active and
spo2 maintained at >95% for five minutes on room air. Pain was assessed after tracheal extubation and
reassessed after ten minutes on numerical rating scale. we used the Rikers sedation agitation scale
which was developed to assess the level of agitation and sedation from the time
of turning off sevoflurane, during extubation and immediate post anesthesia
period (5-15mins). We divided the patient in to two categories
using Riker sedation scale: Non agitated patients (levels 1- 4) and agitated
patients (level: 5-7). We then subdivided those patients in agitated
group as agitated, very agitated, and dangerously agitated. Agitation
was correlated with following factors: 1. age 2. gender 3. duration of surgery
4. comorbidities 5. alcoholism 6. postop pain. Emergence delirium is often
treated with combination of Non pharmacological and pharmacological
interventions. Non pharmacological strategies include reassuring the patient,
managing pain with analgesics. Pharmacological
options which include administering intravenous bolus of sedative agents like
midazolam (0.03-0.1mg/kg iv) or propofol (0.5- 1mg/kg iv) or opioids like
fentanyl (0.5-1mcg/kg iv) are used. Other
drugs used in treating emergence delirium are ketamine ( 0.25mg/kg iv),
Dexmedetomidine (0.3- 1 mcg/kg iv), clonidine (2-3mcg/kg iv).
REFERENCES- Yu D., Chai W., Sun X., et al. Emergence agitation in
adults: risk factors in 2000 patients. Can J Anesth. 2010;57:843–848. doi:
10.1007/s12630-010-9338-9.
Lepouse C., Lautner C.A., Liu L., et al. Emergence delirium
in adults in the post-anesthesia care unit. Br J Anaesth. 2006;96:747–753. doi:
10.1093/bja/ael094.
Scott G.M., Gold J.I. Emergence delirium: a re-emerging
interest. Sem Anesth Perioperat Pain Med. 2006;25:100–104.
G.L., Nejad S.H., Esses J.A., et al. Postoperative delirium.
Am J Psychiatry. 2008;165:803–812. doi: 10.1176/appi.ajp.2008.08020181.
Fricchione |