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To find out which drug (dexmedetomidine or midazolam) will provide better sedation and patient satisfaction in deviated nasal septum corrective surgery under local anaesthesia.

Comparison Between Dexmedetomidine And Midazolam Infusions For Procedural Sedation During Septoplasty Under Local Anaesthesia â?? Randomized Double Blind Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/08/007182
Enrollment
60
Registered
2016-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients diagnosed as deviated nasal septum posted for elective septoplasty

Interventions

Intervention1: Dexmedetomidine: Infusion. Dexmedetomidine 1µg/kg over 10 minutes followed by continuous infusion of 0.5µg/kg/hr. infusion stopped 10 min before the end of surgery. Control Interventi

Sponsors

No
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 60 ASA physical status I-II interested patients, aged between 18 and 50 years undergoing elective septoplasty under local anaesthesia were included.

Exclusion criteria

Exclusion criteria: We excluded Mallampati class 3 & 4, obese, obstructive sleep apnoea, difficult airway patients, patients with liver, cardiovascular, haematological, psychiatric disorders, known hypersensitivity to dexmedetomedine or midazolam, substance abusers, hypertensives (SBP >150 mmHg, DBP >90 mmHg), patients taking beta blocker therapy, guanethedine, cardiac glycoside.

Design outcomes

Primary

MeasureTime frame
sedation efficacy comparison patient satisfaction score Timepoint: assessment of sedation every 10 minutes using Ramsay sedation score patient satisfaction assessment—

Secondary

MeasureTime frame
Heart rate Systolic blood pressure Diastolic blood pressure Mean arterial pressure Oxygen saturation Respiratory rate Rescue fentanyl requirement Surgeon satisfaction scoreTimepoint: assessment done every 10 minutes during procedure monitored 2 hours in recovery room post operatively—

Countries

India

Contacts

Public ContactSiyam Sundar E

Mahathma gandhi medical college and research institute

dr.sameerjahagirdar786@gmail.com9790018478

Outcome results

None listed

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