| CTRI Number |
CTRI/2026/03/106072 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Can midazolam injection added to standard medicines help prevent nausea and vomiting after laparoscopic surgery in women ? |
|
Scientific Title of Study
|
Effect Of Adding Intravenous Midazolam To A Dual Post Operative Nausea And Vomiting Regimen In Female Patients Undergoing Laparoscopic Surgeries - A Prospective Randomized Control 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 Santosh Tharwani |
| Designation |
Associate Professor |
| Affiliation |
Shri Balaji Institute Of Medical Science , Mowa Raipur CG |
| Address |
Department Of Anaesthesiology
Shri Balaji Institute Of Medical Science Mowa Raipur CG
Raipur
CHHATTISGARH
492014
India |
| Phone |
8602297811 |
| Fax |
|
| Email |
pallavmungutwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reema Wadhawa |
| Designation |
Professor and Head Of Department |
| Affiliation |
Shri Balaji Institute of Medical Science , Mowa Raipur CG |
| Address |
Department Of Anaesthesiology
Shri Balaji Institute Of Medical Science Mowa Raipur CG
Raipur
CHHATTISGARH
492014
India |
| Phone |
9265623026 |
| Fax |
|
| Email |
Reema.tavar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallav Mungutwar |
| Designation |
PG Resident |
| Affiliation |
Shri Balaji Institute of Medical Science , Mowa Raipur CG |
| Address |
Department Of Anaesthesiology
Shri Balaji Institute Of Medical Science Mowa Raipur CG
House No 7 , State Bank Colony Fafadih Raipur CG
Raipur
CHHATTISGARH
492014
India |
| Phone |
7999894380 |
| Fax |
|
| Email |
pallavmungutwar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shri Balaji Institute Of Medical Sciences Institutional Sponsor |
| Address |
Institutional Ethics Committee Shri Balaji Hospital Campus
Dubey Colony Mowa Raipur Chhattisgarh
Pin code 492014
Country India |
| 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 Reema Wadhawa |
Shri Balaji Institute of Medical Sciences Hospital Raipur CG |
Department of Anaesthesiology
7th floor
Hospital Building
Raipur
CHHATTISGARH |
9265623026
Reema.tavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SBIMS Mowa Raipur CG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect Of Adding Intravenous Midazolam To A Dual Post Operative Nausea And Vomiting Regimen In Female Patients Undergoing Laparoscopic Surgeries - A Prospective Randomized Control Trial. |
Eligible patients will be randomly assigned to either the control group (receiving conventional dual regimen) or the intervention group (receiving midazolam (with low-dose dexamethasone (4 mg)-ondansetron) using a computer-generated block of four randomizations that were centrally constructed through an online system.
Before surgery, patients were not administered premedication consisting of benzodiazepines or antiemetics. Anesthetic management was the responsibility of the intraoperative anesthesiologist, which included airway management, induction agents, volatile agents, muscle relaxants, ventilator settings, fluid administration, and analgesia, except for nitrous oxide avoidance. The patients were administered the study medication, which was prepared by a nurse anesthetist who did not participate in patient care, following the standard procedure for inducing anesthesia.
The dexamethasone doses for both groups were prepared in equal amounts by diluting with normal saline and were packed in a syringe labeled “Research drug no. 1.” Subsequently, 30 min before the end of surgery, all patients in both groups received 4 mg of ondansetron and “Research drug no. 2,” which in the intervention group consisted of midazolam 0.04 mg/kg (maximum of 2 mg) or the equivalent volume of normal saline in the control group.
Intervention Group (study group) - receiving midazolam (with low-dose dexamethasone (4 mg)-ondansetron).
|
| Comparator Agent |
Effect Of Adding Intravenous Midazolam To A Dual Post Operative Nausea And Vomiting Regimen In Female Patients Undergoing Laparoscopic Surgeries - A Prospective Randomized Control Trial. |
Eligible patients will be randomly assigned to either the control group (receiving conventional dual regimen) or the intervention group (receiving midazolam (with low-dose dexamethasone (4 mg)-ondansetron) using a computer-generated block of four randomizations that were centrally constructed through an online system.
Before surgery, patients were not administered premedication consisting of benzodiazepines or antiemetics. Anesthetic management was the responsibility of the intraoperative anesthesiologist, which included airway management, induction agents, volatile agents, muscle relaxants, ventilator settings, fluid administration, and analgesia, except for nitrous oxide avoidance. The patients were administered the study medication, which was prepared by a nurse anesthetist who did not participate in patient care, following the standard procedure for inducing anesthesia.
The dexamethasone doses for both groups were prepared in equal amounts by diluting with normal saline and were packed in a syringe labeled “Research drug no. 1.” Subsequently, 30 min before the end of surgery, all patients in both groups received 4 mg of ondansetron and “Research drug no. 2,” which in the intervention group consisted of midazolam 0.04 mg/kg (maximum of 2 mg) or the equivalent volume of normal saline in the control group.
Control group (comparator group) - receiving conventional dual regimen (high-dose dexamethasone (8 mg)- ondansetron). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
(1)Age group : 18 - 65 years.
(2)Gender : Female patients.
(3)ASA grades : ASA grade I and II.
(4)BMI : 18 - 40 kg/m^2.
(5)Patients posted for elective laparoscopic surgeries.
(6)Patients willing to participate and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Patient refusal.
Body mass index less than 18 kg per square meter or greater than 40 kg per square meter.
Known allergy or contraindication to study drugs.
History of chronic postoperative nausea and vomiting, chronic headache, or psychiatric disorder.
Chronic opioid use for more than 3 months or chronic benzodiazepine use.
Pregnancy.
Prior anticancer chemotherapy within 4 weeks before surgery.
Obstructive sleep apnea.
Poorly controlled diabetes mellitus defined as HbA1c greater than 9 percent or blood glucose level greater than 180 mg per deciliter on the day of surgery. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of PONV in patients receiving midazolam with low dose dexamethasone(4mg)- ondansetron Vs control group receiving conventional dual regimen high dose dexamethasone(8mg)-ondansetron. |
To compare the incidence of PONV in patients receiving midazolam with low dose dexamethasone(4mg)- ondansetron Vs control group receiving conventional dual regimen high dose dexamethasone(8mg)-ondansetron.
The primary outcome will be the incidence of PONV within 24 hours.
PONV will be assessed at 0, 0–2, 2–6, 6–12, and 12–24 hr postoperatively using the PONV score,[11] which will range from 0 to 3 (0 = no nausea or vomiting, 1 = nausea, 2 = retching, which means an involuntary attempt to vomit without expulsion of gastric content, and 3 = vomiting). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Severity of PONV by VAS.
Need for rescue anti emetics, and analgesics.
Patient satisfaction
|
24 hours post operatively. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
25/03/2026 |
| 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="2"
Months="0"
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
|
This prospective randomized controlled trial evaluates the effect of adding intravenous midazolam to a dual antiemetic regimen for preventing postoperative nausea and vomiting PONV in female patients undergoing laparoscopic surgeries PONV is a common and distressing complication with an incidence of 60 to 80 percent in high-risk patients Standard prophylaxis includes dexamethasone and ondansetron however PONV remains significant despite dual therapy Midazolam a short acting benzodiazepine has demonstrated additional antiemetic properties via GABA mediated mechanisms
A total of 200 ASA I and II female patients 18 to 65 years will be randomized into two groups Group A will receive dexamethasone 8 mg with ondansetron 4 mg, while Group B will receive dexamethasone 4 mg ondansetron 4 mg and midazolam 0.04 mg/kg maximum 2 mg PONV incidence within 24 hours is the primary outcome Secondary outcomes include severity VAS rescue antiemetic requirement pain scores sedation patient satisfaction and blood glucose levels The study hypothesizes that midazolam addition significantly reduces PONV incidence and severity |