| CTRI Number |
CTRI/2024/02/062535 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of increasing the number of respiration in one minute on blood pressure and heartbeat per minute of patients undergoing gall bladder surgery by laparoscopic method. |
|
Scientific Title of Study
|
Effect of Hyperventilation Prior to CO2 Insufflation in Laparoscopic Cholecystectomy: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shuchi Nigam |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai,Etawah |
| Address |
Department of Anaesthsia, UPUMS Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7017954040 |
| Fax |
|
| Email |
shuchinigam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shuchi Nigam |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai,Etawah |
| Address |
Department of Anaesthsia, UPUMS Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7017954040 |
| Fax |
|
| Email |
shuchinigam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shuchi Nigam |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai,Etawah |
| Address |
Department of Anaesthsia, UPUMS Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7017954040 |
| Fax |
|
| Email |
shuchinigam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar pradesh university of medical sciences, Saifai |
|
|
Primary Sponsor
|
| Name |
Uttar pradesh university of medical sciences |
| Address |
Department of Anaesthesiology, UPUMS, Saifai Etawah
206130
Uttar Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shuchi Nigam |
Uttar pradesh university of medical sciences, SAIFAI |
Department of Anaesthsia, UPUMS Saifai
Etawah
UTTAR PRADESH |
-917017954040
shuchinigam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttar Pradesh University of Medical SciencesSaifai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyperventilation Group |
the patients will be ventilated with a TV of 8 mL.kg-1 with the adjustment of the R.R to maintain an ETCO2 of 30-35mm Hg, starting from 15 min prior to insuffalation.Â
|
| Comparator Agent |
Normal ventilation Group |
the patients will be ventilated with a tidal volume (TV) of about 8 mL.kg-1 and respiratory rate (R.R) will be adjusted to maintain an end-tidal CO2 (ETCO2) of 35-40mm of Hg starting from 15 min prior to insuffalation. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA physical status I & II undergoing elective laparoscopic cholecystectomy
|
|
| ExclusionCriteria |
| Details |
Patient Refusal
Pregnancy
Obesity
Smokers |
|
|
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 |
| Mean Arterial Pressure |
at baseline and Induction and then every 5 min till completion of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart Rate and SPO2 |
at baseline and Induction and then every 5 min till completion of surgery. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
01/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Laparoscopic surgery is nowadays a routinely performed procedure worldwide, replacing many types of open surgeries. The most commonly used gas for insufflation is carbon dioxide.
Absorption of carbon dioxide (CO2) from the peritoneal cavity is the potential mechanism for hypercapnia and a rise in the end-tidal carbon dioxide (EtCO2). Mild hypercarbia causes sympathetic stimulation which results in a fivefold increase in arginine vasopressin (AVP), tachycardia, increased systemic vascular resistance, systemic arterial pressure, central venous pressure and cardiac output.
Severe hypercarbia exerts a negative inotropic effect on the heart and reduces left ventricular function. Hemodynamic alterations occur only when the PaCO2 is increased by 30 per cent above the normal levels. We are conducting this research with research question : Are there any significant changes in heart rate, systolic and diastolic pressure and mean arterial pressure due to CO2 insufflation during laproscopic surgery? If YES, then is this change affected by using hyperventilation. All the study patients will undergo a comprehensive pre-operative evaluation . The patients will be randomly divided into two groups using computer generated table and allotted into either of the two groups of 15 each. Group A: the patients will be ventilated with a tidal volume (TV) of about 8 mL.kg-1 and respiratory rate (R.R) will be adjusted to maintain an end-tidal CO2 (ETCO2) of 35-40mm of Hg throughout the procedure, starting from 15 min prior to insuffalation. Group B: the patients’ will be ventilated with a TV of 8 mL.kg-1 with the adjustment of the R.R to maintain an ETCO2 of 30-35mm Hg, throughout the procedure, starting from 15 min prior to insuffalation. Intraabdominal Pressure will be kept between 10-12 mmHg in both the groups. MAP, heart rate, and SpO2 will be measured at baseline and at Induction and then every 5 min till completion of surgery.
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