Improvement and clinical benefit analysis of low-dose esketamine on postoperative pain and sleep after sinus surgery

ISRCTN	ISRCTN68396064
DOI	https://doi.org/10.1186/ISRCTN68396064
Sponsor	Twelfth Guangzhou City People's Hospital
Funder	Guangzhou Municipal Science and Technology Project

Submission date: 21/11/2025
Registration date: 01/12/2025
Last edited: 27/11/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Zi-ping Zhang
Public, Scientific, Principal investigator

Guangzhou Twelfth People's Hospital
Guangzhou
510000
China

Phone	+86 20-38981288
Email	zhangzp202511@126.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Dose comparison
Assignment	Sequential
Purpose	Treatment
Scientific title	Effects of esketamine on postoperative pain and sleep
Study objectives	To investigate the benefits of low-dose esketamine for pain relief and sleep quality improvement after sinus surgery，and stable hemodynamics during perioperative period.
Ethics approval(s)	Approved 20/07/2021, The Human Research Ethics Committee of the Guangzhou Twelfth People's Hospital (Guangzhou Twelfth People's Hospital, Guangzhou, 510000, China; +86 20-38661509; srx8255@163.com), ref: 2021059
Health condition(s) or problem(s) studied	Sinusitis and were scheduled to undergo functional endoscopic sinus surgery
Intervention	All patients were required to abstain from food for at least 6 hours and liquids for 2 hours before surgery. Intravenous access was established, and electrocardiogram (ECG), heart rate (HR), pulse oximetry, blood pressure (BP), and bispectral index (BIS) were monitored before induction of anesthesia. The anesthesia protocol was as follows: prior to induction, patients received an intravenous injection of either physiological saline (control group), 0.2 mg/kg ketamine, or 0.3 mg/kg ketamine. Each solution was prepared in a syringe with a volume of 3.0 ml, and one was randomly assigned for use during induction using the online random number table method. Anesthesia was then induced with intravenous injection of 0.1 mg/kg propofol medium/long-chain fat emulsion (1.0–2.0 mg/kg), 0.5 μg/kg sufentanil, and 0.2 mg/kg cisatracurium. After intubation under visual laryngoscopy, patients were connected to an anesthesia machine for mechanical ventilation. Ventilator parameters were adjusted according to patient condition, maintaining end-tidal carbon dioxide between 35 and 45 mmHg. Cisatracurium was administered intermittently during surgery. For anesthesia maintenance, patients received inhalation of 1.0–3.0 VOL% sevoflurane (0.65–1.70 times the minimum alveolar concentration [MAC]) and 2.0–6.0 mg/kg/h propofol, with BIS maintained between 40 and 60. Blood pressure was controlled to achieve a 20% reduction from baseline, using nitroglycerin or vasopressors if necessary. General anesthesia drugs were discontinued near the end of surgery. All patients received anesthesia from the same team of anesthesiologists. Postoperative data were collected by an anesthesiologist specializing in data collection. The anesthesiologist, physician, and patients were blinded to group assignments during data collection.
Intervention type	Mixed
Primary outcome measure(s)	Pain measured using visual analogue scale (VAS) at before and after treatment Sleep measured using Pittsburgh Sleep Quality Index (PSQI) at before and after treatment Depression measured using Hamilton Depression Rating Scale (HAM-D) at before and after treatment Anxiety measured using Hamilton Anxiety Rating Scale (HAM-A) at before and after treatment Psychological resilience measured using Connor-Davidson Resilience Scale (CD-RISC) at before and after treatment Quality of life measured using Sino-Nasal Outcome Test 20 (SNOT-20) (Chinese version) at before and after treatment
Key secondary outcome measure(s)
Completion date	31/12/2023

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	145
Total final enrolment	135
Key inclusion criteria	1. Those who were 18 to 70 years old 2. Those without severe cardiovascular, respiratory, hepatic, or renal diseases 3. Those with a preoperative American Society of Anesthesiologists (ASA) classification of I to III 4. Those whose operation time was between 8 am and 6 pm 5. Those without a history of peptic ulcer disease 6. Those without a history of addiction to analgesic drugs 7. Those without a history of migraine disease 8. Those who could cooperate with physical examination and pain assessment
Key exclusion criteria	1. Had an operative time of less than 1 hour or more than 3 hours 2. Had an operative bleeding volume of more than 200 ml 3. Patients with intracranial hypertension 4. Psychiatric patients such as schizophrenia, delusional disorders, and epilepsy 5. Patients with severe liver and renal conditions 6. Did not cooperate with postoperative treatment and follow-up visits 7. Allergies to the study medications or developed severe infections after surgery
Date of first enrolment	22/07/2021
Date of final enrolment	23/06/2022

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

24/11/2025: Study's existence confirmed by the Human Research Ethics Committee of the Guangzhou Twelfth People's Hospital.