FindTrial
Sign In

Can midazolam injection added to standard medicines help prevent nausea and vomiting after laparoscopic surgery in women ?

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106072
Enrollment
200
Registered
2026-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K812- Acute cholecystitis with chronic cholecystitis

Interventions

Intervention1: 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

Sponsors

Shri Balaji Institute Of Medical Sciences Institutional Sponsor
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 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

MeasureTime frame
Severity of PONV by VAS. Need for rescue anti emetics, and analgesics. Patient satisfaction Timepoint: 24 hours post operatively.—

Countries

India

Contacts

Public ContactDr Pallav Mungutwar

Shri Balaji Institute of Medical Science , Mowa Raipur CG

Reema.tavar@gmail.com9265623026

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026