CTRI Number |
CTRI/2020/12/029517 [Registered on: 03/12/2020] Trial Registered Prospectively |
Last Modified On: |
13/10/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Efficacy of dexmedetomidine used during surgery for smooth recovery from general anaesthesia in laparoscopic surgeries. |
Scientific Title of Study
|
Efficacy of continuous peri-operative infusion of dexmedetomidine for smooth emergence from general anaesthesia in laparoscopic surgeries. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Hemlata Kamat |
Designation |
Professor |
Affiliation |
H.M.Patel center for medical care and Education |
Address |
Department of Anaesthesiology, Shree Krishna hospital and Pramukh swami Medical College,Anand-Sojitra road, Karamsad
Anand GUJARAT 380325 India |
Phone |
9375031313 |
Fax |
|
Email |
hemlatavk@charutarhealth.org |
|
Details of Contact Person Scientific Query
|
Name |
Dr Hemlata Kamat |
Designation |
Professor |
Affiliation |
H.M.Patel center for medical care and Education |
Address |
Department of Anaesthesiology, Shree Krishna hospital and Pramukh swami Medical College,Anand-Sojitra road, Karamsad
Anand GUJARAT 380325 India |
Phone |
9375031313 |
Fax |
|
Email |
hemlatavk@charutarhealth.org |
|
Details of Contact Person Public Query
|
Name |
Dr Kulin Shrimali |
Designation |
Resident Doctor |
Affiliation |
H.M.Patel center for medical care and education |
Address |
Department of Anaesthesia,Pramukh swami Medical College,Shree Krishna hospital, Gokalnagar, Anand-Sojitra raoad,Karamsad, Anand
Anand GUJARAT 380325 India |
Phone |
7575848969 |
Fax |
|
Email |
kulin.shrimali@gmail.com |
|
Source of Monetary or Material Support
|
Shree Krishna hospital, Anand-Sojitra road,Karamsad,Anand. 388325 |
|
Primary Sponsor
|
Name |
Shree Krishna hospital |
Address |
Gokalnagar,Anand-Sojitra road,Karamsad, Anand, 388325 |
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 Hemlata Kamat |
Shree Krishna hospital |
Surgery and Gynec operation theaters, 1st floor , Shree Krishna hospital ,Gokalnagar,Anand-Sojitra road,Karamsad.388325 Anand GUJARAT |
9909929422
hemlatavk@charutarhealth.org |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
H.M.Patel center for medical care and education |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, (2) ICD-10 Condition: R688||Other general symptoms and signs, (3) ICD-10 Condition: R688||Other general symptoms and signs, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Continuous intravenous dexmedetomidine infusion |
Inj Dexmedetomidine loading dose of 1 mcg/kg over 15 minutes;(20 minutes before the start of surgery) followed by continuous intravenous dexmedetomidine infusion at the rate of 0.4 mcg/kg will be given in control group till pnuemoperitoneum will be deflated by surgeon. |
Intervention |
Continuous Intravenous dexmedetomidine infusion |
Inj Dexmedetomidine loading dose of 1 mcg/kg over 15 minutes;(20 minutes before the start of surgery) followed by continuous intravenous dexmedetomidine infusion at the rate of 0.4 mcg/kg will be given in study group till the time of administration of neostigmine (reversal agent). |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients with ASA grade 1,2,3 physical status undergoing elective laparoscopic surgeries under general anaesthesia with estimated time of 1-3 hours. |
|
ExclusionCriteria |
Details |
1)Known allergy for dexmedetomidine
2)Obese(BMI >35kg/m2)
3)Febrile
4)Pregnant females
5)Patients who is on antidepressants or opioid or non-opioid analgesics.
6)Pulse rate <60min |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To observe the effect of IV dexmedetomidine on quality of emergence from general anaesthesia in terms of cough suppression and agitation. |
Post surgery at every 5 minutes( 0min, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min) |
|
Secondary Outcome
|
Outcome |
TimePoints |
To observe the effect of IV dexmedetomidine on quality of emergence from general anaesthesia in terms of shivering and heamodynamics and time to extubation. |
Post surgery at every 5 minutes( 0min, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min).
Time to Extubation measured from switching off sevoflourane to removal of endotracheal tube. |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
04/12/2020 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="10" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
After Obtaining ethical committee approval and patient’s written and informed consent, patients of ASA I/II/III physical status who will be undergoing elective laparoscopic surgery under general anaesthesia with estimated time of 1-3 hours will be recruited to participate in randomized controlled trial. The participant would be randomly allocated to group C or group D by computer generated random numbers. Results of randomization will be kept in concealed opaque envelopes and opened sequentially immediately before study drug administration. Routine monitors will be applied including BP cuff, electrocardiogram leads, Pulse oximeter probe, capnometry , esophageal temperature probe , peripheral nerve stimulator using Train of four(TOF) throughout the surgery. In all patients Inj dexmedetomidine loading dose (1µg/kg) over 15mins will be given followed by an infusion, at the rate of 0.4µg/kg/hr started 20mins prior to induction. Anaesthesia will be induced using IV Glycopyrrolate 0.04mg/kg mg, IV fentanyl 2 µg/kg, IV xylocard 1.5 mg/kg, IV Propofol and 1.5-2 mg/kg, Vecuronium 0.1 mg/kg or scoline 2mg/kg depending on the airway management. After orotracheal intubation and Ryles tube insertion, anaesthesia will be maintained using O2+air, sevoflurane 1%-3% , using low flows (1-2 lits) in close circuit and volume controlled ventilation with tidal volume 7ml/kg and respiratory rate of 10-14 in order to maintain the ETCO2 around 30mmHg with FIO2 of 50%. Intermittent doses of Inj fentanyl will be given every hourly to keep the blood pressure and heart rate within 20% of baseline and Inj. vecuronium will be titrated according to TOF monitoring i.e. will be repeated on appearance of three twitches. In control group, when pneumoperitoneum will be deflated by surgeon, dexmedetomidine infusion will be stopped. In experimental group D, dexmedetomidine infusion will be continued till the time of administration of neostigmine(reversal agent), when all four twitches of equal amplitude will be obtained on TOF stimulation. In all patients, at the end of surgery (skin suturing completed), Sevoflurane will be stopped (Defined as time zero or baseline of emergence process), fresh gas flow will be increased to 4-6lit/min, and Ondansetron 4 mg IV will be given and Orogasric suction will be performed. From Time zero till 15 minutes post extubation, systolic BP, Diastolic BP , heart rate, Spo2 and end tidal CO2, Agitation, Cough Scores and no. of coughing episodes will be recorded every 5 minutes. Patient will be reversed with Inj neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg,.Trachea will be extubated when patient will be awake, spontaneous eye opening and reflexes present. The following will be recorded: total duration of anaesthesia and duration of surgery and time to extubation. Time to Extubation is defined as Time from switching off the sevoflurane to removal of the endotracheal tube. Duration of surgery will be defined as time of skin incision to completion of skin suturing. Duration of anaesthesia will be defined as time from induction by propofol to reversal with inj neostigmine and glycopyrrolate. |