Observation of the Sedative and Anti-anxiety Effects and Safety of Preoperative Intranasal Dexmedetomidine Administration at Various Doses in Patients Undergoing Gynecological Laparoscopic Surgery

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500109431

Enrollment

Unknown

Registered

2025-09-18

Start date

2025-09-22

Completion date

Unknown

Last updated

2025-09-22

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

Conditions

Preoperative anxiety

Interventions

Control group:In the control group, the same volume of normal saline was given by nasal spray 45-60min before operation, which was completed within 2min

Dexmedetomidine D1 group:Dexmedetomidine hydrochloride nasal spray 50ug (2 sprays) was administered intranasal 45 to 60min before surgery and completed within 2min

Dexmedetomidine D2 group:Dexmedetomidine hydrochloride nasal spray 100ug (4 sprays) was administered intranasal 45 to 60min before surgery and completed within 2min

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) planned to undergo elective gynecological laparoscopic surgery; (2) American Society of Anesthesiologists (ASA) grade ?-?; (3) Female, aged 18-70 years; (4) Body mass index (BMI) 18-30kg/m^2; (5) ability of reading and comprehension; (6) Informed about the study, voluntarily participated and included in the study

Exclusion criteria

Exclusion criteria: (1) allergic to dexmedetomidine or other anesthetic drugs; (2) persistent low heart rate (<45 beats/min) or moderate to severe atrioventricular block (second or third degree); (3) patients with severe hypertension, severe asthma and sleep apnea syndrome; (4) severely damaged heart, liver, kidney and other important organs; (5) patients with mental illness or other disorders affecting communication; (6) long-term use or abuse of analgesics and sedatives; (7) patients with respiratory diseases; (8) pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Ramsay Sedation Scale;Bispectral index (BIS);Visual analog scale for anxiety (VAS-A);	—

Secondary

Measure	Time frame
Vital signs at different points in time;Anesthesia and operation related time;Adverse Cardiovascular Events;Other adverse events during anesthesia recovery period;VAS score of venipuncture pain;Patient satisfaction with anesthesia at the time of leaving the POstanesthesia care unit;	—

Countries

CHINA

Contacts

Public ContactShiyu Peng

Wuhan Central Hospital

pengshiyu779@163.com+86 183 7576 2576

Outcome results

None listed

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