| CTRI Number |
CTRI/2018/03/012473 [Registered on: 12/03/2018] Trial Registered Prospectively |
| Last Modified On: |
07/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trail to study the effect of two drugs desflurane and sevoflurane in adults after laparoscopic surgery. |
|
Scientific Title of Study
|
A randomized controlled comparison of emergence agitation and recovery profile between desflurane and sevoflurane anaesthesia in adults after laparoscopic surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dolly M Gedam |
| Designation |
PGJR |
| Affiliation |
Government medical college and hospital, Chandigarh |
| Address |
Department of anaesthesia and intensive care,
GMCH, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9988471148 |
| Fax |
|
| Email |
dollygdm5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dheeraj Kapoor |
| Designation |
Associate Professor |
| Affiliation |
Government medical college and hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care,
GMCH, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121549 |
| Fax |
|
| Email |
kapoor.dheeraj72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dheeraj Kapoor |
| Designation |
Associate Professor |
| Affiliation |
Government medical college and hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care,
GMCH, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121549 |
| Fax |
|
| Email |
kapoor.dheeraj72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director Principal, Government Medical College and Hospital,Sector 32,Chandigarh |
|
|
Primary Sponsor
|
| Name |
Director Principal |
| Address |
Government medical college and hospital, Sector 32, Chandigarh |
| Type of Sponsor |
Government 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 |
| Dolly M Gedam |
Government medical college and hospital |
Department of Anaesthesia and Intensive care,Block D,Floor 5th,Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9988471148
dollygdm5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,GMCH,CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing laparoscopic surgery under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
desflurane |
inhalational anaesthetic agent |
| Comparator Agent |
sevoflurane |
inhalational anaesthetic agent |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 18 and 60 years.
2. American Society of Anaesthesiologist (ASA) physical status I and II
3. Patients scheduled for elective laparoscopy surgery under general anaesthesia with duration of surgery less than 90 minutes. |
|
| ExclusionCriteria |
| Details |
1. Patients with clinically significant cardiovascular, respiratory, hepato-renal, endocrine or metabolic disorders.
2. Patients with gastro-esophageal reflux disease.
3. Patients with neuropsychiatric disorders.
4. Patients with mental retardation.
5. Patients with a body mass index (BMI) > 35 kg.m.-2
6. Patients taking any central nervous system depressants.
7. Patients on chronic opioids, corticosteroids or any sleep aid drugs.
8. Patients having alcohol or any drug abuse. 9. Patients with any allergy to study drugs. 10.Pregnant and breastfeeding patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of emergence agitation by Aonos Four point Scale |
1.Immediately after the PLMA is removed in the Operating Room.
2.At admission in PACU. 3.Thereafter every 10 minutes in the recovery period, till the patient is discharged from PACU. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Recovery by QOR-40 score. |
1.The day before surgery (baseline)
2.Postoperative day one (POD1,around 24 hours after surgery)
3.Postoperative day two (POD2, around 48 hours after surgery). |
| Severity of anxiety using an 11-point numeric rating score (NRS) |
1.In Preoperative room.
2.Immediately upon arrival in the PACU
3.Thereafter every 10 minutes in the recovery period, till the patient is discharged from PACU. |
| Severity of pain using an 11-point numeric rating score (NRS) |
1.In Preoperative room.
2.Immediately upon arrival in the PACU
3.Thereafter every 10 minutes in the recovery period, till the patient is discharged from PACU. |
| Severity of nausea/vomiting using an 11-point numeric rating score (NRS) |
1.In Preoperative room.
2.Immediately upon arrival in the PACU
3.Thereafter every 10 minutes in the recovery period, till the patient is discharged from PACU. |
| Heart Rate |
1.Prior to induction
2.Ten minutes after induction.
3.After PLMA removal.
4.At admission in PACU.
5.Immediately Prior to discharge from PACU. |
| Non Invasive Blood Pressure |
1.Prior to induction
2.Ten minutes after induction.
3.After PLMA removal.
4.At admission in PACU.
5.Immediately Prior to discharge from PACU |
| Mean Arterial Pressure |
1.Prior to induction
2.Ten minutes after induction.
3.After PLMA removal.
4.At admission in PACU.
5.Immediately Prior to discharge from PACU |
| Saturation of Oxygen in Blood. |
1.Prior to induction
2.Ten minutes after induction.
3.After PLMA removal.
4.At admission in PACU.
5.Immediately Prior to discharge from PACU. |
| Any perioperative complications |
Perioperative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/03/2018 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Laparoscopic surgery is one of the most important
diagnostic and therapeutic tools in the present surgical practice and has
become the gold standard of minimal access surgery. The benefits of minimal
access techniques include less pain, early mobilization, improved cosmetic
aspects and shorter hospital stay, which have further increased its
applications.The major problems during laparoscopic surgery are related to the
cardiopulmonary effect of pneumoperitoneum, systemic carbon dioxide absorption,
venous gas embolism, unintentional injuries to intraabdominal structures and
patient positioning.Anaesthesia and surgery have certain inevitable negative
impacts on the quality of life of patients, manifest as various discomforts
after surgery even without specific complications. Moreover, prolonged recovery
after surgery can lead to delayed hospital discharges and increased costs,
which can impact resource utilization and mitigate patient satisfaction.Quality
of recovery directly highlight the late recovery profile and reflects the
high-quality anaesthetic services in an economically constrained healthcare
environment.Emergence agitation (EA) after general anaesthesia is a pressing
concern for anaesthesiologists, commonly seen in immediate post anaesthetic
period.During the last few decades, the new volatile anaesthetics, sevoflurane
and desflurane became commonly available in clinical practice.The
pharmacokinetic properties of sevoflurane and desflurane offer firm control of
anaesthesia and reduce the time for emergence from general anaesthesia, there
by reducing procedure time and have the capacity to make anaesthesia even safer
in high risk patients.Presently, the emergence effects of aforesaid
inhalational anaesthetics is still not fully elucidated in adults.We
hypothesized that difference in the intrinsic characteristics and the speed of
emergence, of the two inhalational anaesthetics, would have direct effect on
the progression of emergence agitation and recovery profile in adults. The aim
of this prospective randomized double-blind study is to compare emergence
agitation and recovery profile between desflurane and sevoflurane anaesthesia
in adult patients undergoing laparascopic surgery.we will be using Qor-40
score, which is now one of the most recent and extensively validated
rating scale to measure the quality of recovery after surgery and anaesthesia
in clinical and research situations. and also to evaluate the severity of
emergence state by using a four-point categorical scale based on Aono‘s scale. |